Drug project high-priority medications: Difference between revisions
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==WikiDoc Drug Project — High-Priority Medications== | ==WikiDoc Drug Project — High-Priority Medications== | ||
* Template here: [[Drug page template]] | *Template here: [[Drug page template]] | ||
* Example here: [[Clopidogrel]] | *Example here: [[Clopidogrel]] | ||
* FDA package insert here: [https://dailymed.nlm.nih.gov/dailymed/ DailyMed] | *FDA package insert here: [https://dailymed.nlm.nih.gov/dailymed/ DailyMed] | ||
==List of high-priority medications== | ==List of high-priority medications== | ||
=== Novel Drug Approvals for 2023 === | |||
{| class="wikitable" | {| class="wikitable" | ||
! No. !! Drug Name !! Active Ingredient !! Approval Date !! FDA-approved use on approval date | |||
|- | |- | ||
| | |55 | ||
|Wainua | |||
|eplontersen | |||
|12/21/2023 | |||
|To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis | |||
|- | |- | ||
| | |54 | ||
|Filsuvez | |||
|birch triterpenes | |||
|12/18/2023 | |||
|To treat wounds associated with dystrophic and junctional epidermolysis bullosa | |||
|- | |- | ||
| | | 53 || Fabhalta || iptacopan || 12/5/2023 || To treat paroxysmal nocturnal hemoglobinuria | ||
|- | |- | ||
| | | 52 || Ogsiveo || nirogacestat || 11/27/2023 || To treat adults with progressing desmoid tumors who require systemic treatment | ||
|- | |- | ||
| | | 51 || Truqap || capivasertib || 11/16/2023 || To treat breast cancer that meets certain disease criteria | ||
|- | |- | ||
| | | 50 || Ryzneuta || efbemalenograstim alfa-vuxw || 11/16/2023 || To treat neutropenia | ||
|- | |- | ||
| | | 49 || Augtyro || repotrectinib || 11/15/2023 || To treat ROS1-positive non-small cell lung cancer | ||
|- | |- | ||
| | | 48 || Defencath || taurolidine, heparin || 11/15/2023 || To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter | ||
|- | |- | ||
| | | 47 || Fruzaqla || fruquintinib || 11/08/23 || To treat refractory, metastatic colorectal cancer | ||
|- | |- | ||
| | | 46 || Loqtorzi || toripalimab-tpzi || 10/27/2023 || To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies | ||
|- | |- | ||
| | | 45 || Omvoh || mirikizumab-mrkz || 10/26/2023 || To treat ulcerative colitis | ||
|- | |- | ||
| | | 44 || Agamree || vamorolone || 10/26/2023 || To treat Duchenne muscular dystrophy | ||
|- | |- | ||
| | | 43 || Bimzelx || bimekizumab || 10/17/2023 || To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy | ||
|- | |- | ||
| | | 42 || Zilbrysq || zilucoplan || 10/17/2023 || To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive | ||
|- | |- | ||
| | | 41 || Velsipity || etrasimod || 10/12/23 || To treat moderately to severely active ulcerative colitis in adults | ||
|- | |- | ||
| | | 40 || Rivfloza || nedosiran || 9/29/2023 || To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function | ||
|- | |- | ||
| | | 39 || Pombiliti || cipaglucosidase alfa-atga || 9/28/2023 || To treat late-onset Pompe disease | ||
|- | |- | ||
| | | 38 || Exxua || gepirone || 9/22/2023 || To treat major depressive disorder | ||
|- | |- | ||
| | | 37 || Ojjaara || momelotinib || 9/15/2023 || To treat intermediate or high-risk myelofibrosis in adults with anemia | ||
|- | |- | ||
| | | 36 || Aphexda || motixafortide || 09/08/23 || To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma | ||
|- | |- | ||
| | | 35 || Veopoz || pozelimab-bbfg || 8/18/2023 || To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease | ||
|- | |- | ||
| | | 34 || Sohonos || palovarotene || 8/16/2023 || To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva | ||
|- | |- | ||
| | | 33 || Elrexfio || elranatamab-bcmm || 8/14/2023 || To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy | ||
|- | |- | ||
| | | 32 || Talvey || talquetamab-tgvs || 08/09/23 || To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies | ||
|- | |- | ||
| | | 31 || Izervay || avacincaptad pegol || 08/04/23 || To treat geographic atrophy secondary to age-related macular degeneration | ||
|- | |- | ||
| | | 30 || Zurzuvae || zuranolone || 08/04/23 || To treat postpartum depression | ||
|- | |- | ||
| | | 29 || Xdemvy || lotilaner || 7/25/2023 || To treat Demodex blepharitis | ||
|- | |- | ||
| | | 28 || Vanflyta || quizartinib || 7/20/2023 || To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria | ||
|- | |- | ||
| | | 27 || Beyfortus || nirsevimab-alip || 7/17/2023 || To prevent respiratory syncytial virus (RSV) lower respiratory tract disease | ||
|- | |- | ||
| | | 26 || Ngenla || somatrogon-ghla || 6/27/2023 || To treat growth failure due to inadequate secretion of endogenous growth hormone | ||
|- | |- | ||
| | | 25 || Rystiggo || rozanolixizumab-noli || 6/26/2023 || To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive | ||
|- | |- | ||
| | | 24 || Litfulo || ritlecitinib || 6/23/2023 || To treat severely patchy hair loss | ||
|- | |- | ||
| | | 23 || Columvi || glofitamab-gxbm || 6/15/2023 || To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy | ||
|- | |- | ||
| | | 22 || Inpefa || sotagliflozin || 5/26/2023 || To treat heart failure | ||
|- | |- | ||
| | | 21 || Posluma || flotufolastat F 18 || 5/25/2023 || To use with positron emission tomography imaging in certain patients with prostate cancer | ||
|- | |- | ||
| | | 20 || Paxlovid || nirmatrelvir, ritonavir || 5/25/2023 || To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 | ||
|- | |- | ||
| | | 19 || Xacduro || sulbactam, durlobactam || 5/23/2023 || To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex | ||
|- | |- | ||
| | | 18 || Epkinly || epcoritamab-bysp || 5/19/2023 || To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy | ||
|- | |- | ||
| | | 17 || Miebo || perfluorhexyloctane || 5/18/2023 || To treat signs and symptoms of dry eye disease | ||
|- | |- | ||
| | | 16 || Veozah || fezolinetant || 05/12/23 || To treat moderate to severe hot flashes caused by menopause | ||
|- | |- | ||
| | | 15 || Elfabrio || pegunigalsidase alfa-iwxj || 05/09/23 || To treat confirmed Fabry disease | ||
|- | |- | ||
| | | 14 || Qalsody || tofersen || 4/25/2023 || To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation | ||
|- | |- | ||
| | | 13 || Joenja || leniolisib || 3/24/2023 || To treat activated phosphoinositide 3-kinase delta syndrome | ||
|- | |- | ||
| | | 12 || Rezzayo || rezafungin || 3/22/2023 || To treat candidemia and invasive candidiasis | ||
|- | |- | ||
| | | 11 || Zynyz || retifanlimab-dlwr || 3/22/2023 || To treat metastatic or recurrent locally advanced Merkel cell carcinoma | ||
|- | |- | ||
| | | 10 || Daybue || trofinetide || 03/10/23 || To treat Rett syndrome | ||
|- | |- | ||
| | | 9 || Zavzpret || zavegepant || 03/09/23 || To treat migraine | ||
|- | |- | ||
| | |8 | ||
|Skyclarys | |||
|omaveloxolone | |||
|2/28/2023 | |||
|To treat Friedrich’s ataxia | |||
|- | |- | ||
| | |7 | ||
|Filspari | |||
|sparsentan | |||
|2/17/2023 | |||
|To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression | |||
|- | |- | ||
| | |6 | ||
|Lamzede | |||
|velmanase alfa-tycv | |||
|2/16/2023 | |||
|To treat non-central nervous system manifestations of alpha-mannosidosis | |||
|- | |- | ||
| | |5 | ||
|Jesduvroq | |||
|daprodustat | |||
|02/01/23 | |||
|To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months | |||
|- | |- | ||
| | |4 | ||
|Orserdu | |||
|elacestrant | |||
|1/27/2023 | |||
|To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy | |||
|- | |- | ||
| | |3 | ||
|Jaypirca | |||
|pirtobrutinib | |||
|1/27/2023 | |||
|To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor | |||
|- | |- | ||
| | |2 | ||
|Brenzavvy | |||
|bexagliflozin | |||
|1/20/2023 | |||
|To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise | |||
|- | |- | ||
| 2018||17||Epidioloex||Cannabidiol||[[Cannabidiol]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Epidioloex Epidioloex]||6/25/2018 | |1 | ||
|Leqembi | |||
|lecanemab-irmb | |||
|01/06/23 | |||
|To treat Alzheimer’s disease | |||
|} | |||
===Novel Drug Approvals for 2022=== | |||
{| class="wikitable" | |||
! No. !! Drug Name !! Active Ingredient !! Approval Date !! FDA-approved use on approval date | |||
|- | |||
| 37 || NexoBrid || anacaulase-bcdb || 12/28/2022 || To remove eschar in adults with deep partial thickness or full thickness thermal burns | |||
|- | |||
| 36 || Briumvi || ublituximab-xiiy || 12/28/2022 || To treat relapsing forms of multiple sclerosis | |||
|- | |||
| 35 || Xenoview || hyperpolarized Xe-129 || 12/23/2022 || To evaluate pulmonary function and imaging | |||
|- | |||
| 34 || Lunsumio || mosunetuzumab-axgb || 12/22/2022 || To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma | |||
|- | |||
| 33 || Sunlenca || lenacapavir || 12/22/2022 || To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerationsPress Release | |||
|- | |||
| 32 || Krazati || adagrasib || 12/12/2022 || To treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy | |||
|- | |||
| 31 || Rezlidhia || olutasidenib || 12/1/2022 || To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation | |||
|- | |||
| 30 || Tzield || teplizumab-mzwv || 11/18/22 || To delay the onset of stage 3 type 1 diabetesPress Release | |||
|- | |||
| 29 || Elahere || mirvetuximab soravtansine-gynx || 11/14/2022 || To treat patients with recurrent ovarian cancer that is resistant to platinum therapy | |||
|- | |||
| 28 || Tecvayli || teclistamab-cqyv || 10/25/2022 || To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy | |||
|- | |||
| 27 || Imjudo || tremelimumab || 10/21/2022 || To treat unresectable hepatocellular carcinoma | |||
|- | |||
| 26 || Lytgobi || futibatinib || 9/30/2022 || To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements | |||
|- | |||
| 25 || Relyvrio || sodium phenylbutyrate/taurursodiol || 9/29/2022 || To treat amyotrophic lateral sclerosis (ALS)Press Release | |||
|- | |||
| 24 || Omlonti || oomidenepag isopropyl ophthalmic solution || 9/22/2022 || To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension | |||
|- | |||
| 23 || Elucirem || gadopiclenol || 9/21/2022 || To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body | |||
|- | |||
| 22 || Terlivaz || terlipressin || 9/14/2022 || To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function | |||
|- | |||
| 21 || Rolvedon || eflapegrastim || 9/9/2022 || To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia | |||
|- | |||
| 20 || Sotyktu || deucravacitinib || 9/9/2022 || To treat moderate-to-severe plaque psoriasis | |||
|- | |||
| 19 || Daxxify || daxibotulinumtoixnA-lanm || 9/7/2022 || To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity | |||
|- | |||
| 18 || Spevigo || spesolimab-sbzo || 9/1/2022 || To treat generalized pustular psoriasis flares | |||
|- | |||
| 17 || Xenpozyme || Olipudase alfa || 8/31/2022 || To treat Acid Sphingomyelinase DeficiencyPress Release | |||
|- | |||
| 16 || Amvuttra || vutrisiran || 6/13/2022 || To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis | |||
|- | |||
| 15 || Vtama || tapinarof || 5/23/2022 || To treat plaque psoriasis | |||
|- | |||
| 14 || Mounjaro || tirzepatide || 5/13/2022 || To improve blood sugar control in diabetes, in addition to diet and exercise Press Release | |||
|- | |||
| 13 || Voquezna || vonoprazan, amoxicillin, and clarithromycin || 5/3/2022 || To treat Helicobacter pylori infection | |||
|- | |||
| 12 || Camzyos || mavacamten || 4/28/2022 || To treat certain classes of obstructive hypertrophic cardiomyopathy | |||
|- | |||
| 11 || Vivjoa || oteseconazole || 4/26/2022 || To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential | |||
|- | |||
| 10 || Pluvicto || lutetium (177Lu) vipivotide tetraxetan || 3/23/2022 || To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies | |||
|- | |||
| 9 || Opdualag || nivolumab and relatlimab-rmbw || 3/18/2022 || To treat unresectable or metastatic melanoma | |||
|- | |||
| 8 || Ztalmy || ganaxolone || 3/18/2022 || To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder | |||
|- | |||
| 7 || Vonjo || pacritinib || 2/28/2022 || To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets | |||
|- | |||
| 6 || Pyrukynd || mitapivat || 2/17/2022 || To treat hemolytic anemia in pyruvate kinase deficiency | |||
|- | |||
| 5 || Enjaymo || sutimlimab-jome || 2/4/2022 || To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease | |||
|- | |||
| 4 || Vabysmo || faricimab-svoa || 1/28/2022 || To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema | |||
|- | |||
| 3 || Kimmtrak || tebentafusp-tebn || 1/25/2022 || To treat unresectable or metastatic uveal melanoma | |||
|- | |||
| 2 || Cibinqo || abrocitinib || 1/14/2022 || To treat refractory, moderate-to-severe atopic dermatitis | |||
|- | |||
| 1 || Quviviq || daridorexant || 1/7/2022 || To treat insomnia | |||
|} | |||
===Novel Drug Approvals for 2021=== | |||
{| class="wikitable" | |||
! No. !! Drug Name !! Active Ingredient !! Approval Date !! FDA-approved use on approval date | |||
|- | |||
| 42 || Scemblix || asciminib || 10/29/2021 || To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria | |||
|- | |||
| 41 || Tavneos || avacopan || 10/7/2021 || To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including glucocorticoids | |||
|- | |||
| 40 || Livmarli || maralixibat || 9/29/2021 || To treat cholestatic pruritus associated with Alagille syndrome | |||
|- | |||
| 39 || Qulipta || atogepant || 9/28/2021 || To prevent episodic migraines | |||
|- | |||
| 38 || Tivdak || tisotumab vedotin-tftv || 9/20/2021 || To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy | |||
|- | |||
| 37 || Exkivity || mobocertinib || 9/15/2021 || To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations | |||
|- | |||
| 36 || Skytrofa || lonapegsomatropin-tcgd || 8/25/2021 || To treat short stature due to inadequate secretion of endogenous growth hormone | |||
|- | |||
| 35 || Korsuva || difelikefalin || 8/23/2021 || To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations | |||
|- | |||
| 34 || Welireg || belzutifan || 8/13/2021 || To treat von Hippel-Lindau disease under certain conditions | |||
|- | |||
| 33 || Nexviazyme || avalglucosidase alfa-ngpt || 8/6/2021 || To treat late-onset Pompe disease | |||
|- | |||
| 32 || Saphnelo || anifrolumab-fnia || 7/30/2021 || To treat moderate-to severe systemic lupus erythematousus along with standard therapy | |||
|- | |||
| 31 || Bylvay || odevixibat || 7/20/2021 || To treat pruritus | |||
|- | |||
| 30 || Rezurock || belumosudil || 7/16/2021 || To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy | |||
|- | |||
| 29 || fexinidazole || fexinidazole || 7/16/2021 || To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense | |||
|- | |||
| 28 || Kerendia || finerenone || 7/9/2021 || To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes | |||
|- | |||
| 27 || Rylaze || asparaginase erwinia chrysanthemi (recombinant)-rywn || 6/30/2021 || To treat acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products, as a component of a chemotherapy regimen | |||
|- | |||
| 26 || Aduhelm || aducanumab-avwa || 6/7/2021 || To treat Alzheimer’s disease | |||
|- | |||
| 25 || Brexafemme || ibrexafungerp || 6/1/2021 || To treat vulvovaginal candidiasis | |||
|- | |||
| 24 || Lybalvi || olanzapine and samidorphan || 5/28/2021 || To treat schizophrenia and certain aspects of bipolar I disorder | |||
|- | |||
| 23 || Truseltiq || infigratinib || 5/28/2021 || To treat cholangiocarcinoma whose disease meets certain criteria | |||
|- | |||
| 22 || Lumakras || sotorasib || 5/28/2021 || To treat types of non-small cell lung cancer | |||
|- | |||
| 21 || Pylarify || piflufolastat F 18 || 5/26/2021 || To identify prostate-specific membrane antigen-positive lesions in prostate cancer | |||
|- | |||
| 20 || Rybrevant || amivantamab-vmjw || 5/21/2021 || To treat a subset of non-small cell lung cancer | |||
|- | |||
| 19 || Empaveli || pegcetacoplan || 5/14/2021 || To treat paroxysmal nocturnal hemoglobinuria | |||
|- | |||
| 18 || Zynlonta || loncastuximab tesirine-lpyl || 4/23/2021 || To treat certain types of relapsed or refractory large B-cell lymphoma | |||
|- | |||
| 17 || Jemperli || dostarlimab-gxly || 4/22/2021 || To treat endometrial cancer | |||
|- | |||
| 16 || Nextstellis || drospirenone and estetrol || 4/15/2021 || To prevent pregnancy | |||
|- | |||
| 15 || Qelbree || viloxazine || 4/2/2021 || To treat attention deficit hyperactivity disorder | |||
|- | |||
| 14 || Zegalogue || dasiglucagon || 3/22/2021 || To treat severe hypoglycemia | |||
|- | |||
| 13 || Ponvory || ponesimod || 3/18/2021 || To treat relapsing forms of multiple sclerosis | |||
|- | |||
| 12 || Fotivda || tivozanib || 3/10/2021 || To treat renal cell carcinoma | |||
|- | |||
| 11 || Azstarys || serdexmethylphenidate and dexmethylphenidate || 3/2/2021 || To treat attention deficit hyperactivity disorder | |||
|- | |||
| 10 || Pepaxto || melphalan flufenamide || 2/26/2021 || To treat relapsed or refractory multiple myeloma | |||
|- | |||
| 9 || Nulibry || fosdenopterin || 2/26/2021 || To reduce the risk of mortality in molybdenum cofactor deficiency Type A | |||
|- | |||
| 8 || Amondys 45 || casimersen || 2/25/2021 || To treat Duchenne muscular dystrophy | |||
|- | |||
| 7 || Cosela || trilacicilib || 2/12/2021 || To mitigate chemotherapy-induced myelosuppression in small cell lung cancer | |||
|- | |||
| 6 || Evkeeza || evinacumab-dgnb || 2/11/2021 || To treat homozygous familial hypercholesterolemia | |||
|- | |||
| 5 || Ukoniq || umbralisib || 2/5/2021 || To treat marginal zone lymphoma and follicular lymphoma | |||
|- | |||
| 4 || Tepmetko || tepotinib || 2/3/2021 || To treat non-small cell lung cancer | |||
|- | |||
| 3 || Lupkynis || voclosporin || 1/22/2021 || To treat lupus nephritis | |||
|- | |||
| 2 || Cabenuva || cabotegravir and rilpivirine (co-packaged) || 1/21/2021 || To treat HIV | |||
|- | |||
| 1 || Verquvo || vericiguat || 1/19/2021 || To mitigate the risk of cardiovascular death and hospitalization for chronic heart failure | |||
|} | |||
===Novel Drug Approvals for 2020=== | |||
{| class="wikitable" | |||
! No. !! Drug Name !! Active Ingredient !! Approval Date !! FDA-approved use on approval date | |||
|- | |||
| 53 || Gemtesa || vibegron || 12/23/2020 || To treat overactive bladder | |||
|- | |||
| 52 || Ebanga || ansuvimab-zykl || 12/21/2020 || To treat ebola | |||
|- | |||
| 51 || Orgovyx || relugolix || 12/18/2020 || To treat advanced prostate cancer | |||
|- | |||
| 50 || Margenza || margetuximab (anti-HER2 mAb || 12/16/2020 || To treat HER2+ breast cancer | |||
|- | |||
| 49 || Klisyri || tirbanibulin || 12/14/2020 || To treat actinic Keratosis of the face or scalp | |||
|- | |||
| 48 || Orladeyo || berotralstat || 12/3/2020 || To treat patients with hereditary angioedema | |||
|- | |||
| 47 || Gallium 68 PSMA-11 || Gallium 68 PSMA-11 || 12/1/2020 || For detection and localization of prostate cancer | |||
|- | |||
| 46 || Danyelza || naxitamab-gqgk || 11/25/2020 || To treat high-risk refractory or relapsed neuroblastoma | |||
|- | |||
| 45 || Imcivree || setmelanotide || 11/25/2020 || To treat obesity and the control of hunger associated with pro-opiomelanocortin deficiency, a rare disorder that causes severe obesity that begins at an early age | |||
|- | |||
| 44 || Oxlumo || lumasiran || 11/23/2020 || To treat hyperoxaluria type 1 | |||
|- | |||
| 43 || Zokinvy || lonafarnib || 11/20/2020 || To treat rare conditions related to premature aging | |||
|- | |||
| 42 || Veklury || remdesivir || 10/22/2020 || To treat COVID-19 | |||
|- | |||
| 41 || Inmazeb || atoltivimab, maftivimab, and odesivimab-ebgn || 10/14/2020 || To treat ebola virus | |||
|- | |||
| 40 || Gavreto || pralsetinib || 9/4/2020 || To treat non-small lung cancer | |||
|- | |||
| 39 || Detectnet || copper Cu 64 dotatate injection || 9/3/2020 || To help detect certain types of neuroendocrine tumors | |||
|- | |||
| 38 || Sogroya || somapacitan-beco || 8/28/2020 || Growth hormone | |||
|- | |||
| 37 || Winlevi || clascoterone || 8/26/2020 || To treat acne | |||
|- | |||
| 36 || Enspryng || satralizumab-mwge || 8/14/2020 || To treat neuromyelitis optica spectrum disorder | |||
|- | |||
| 35 || Viltepso || viltolarsen || 8/12/2020 || To treat Duchenne muscular dystrophy | |||
|- | |||
| 34 || Olinvyk || oliceridine || 8/7/2020 || To manage acute pain in certain adults | |||
|- | |||
| 33 || Evrysdi || risdiplam || 8/7/2020 || To treat spinal muscular atrophy | |||
|- | |||
| 32 || Lampit || nifurtimox || 8/6/2020 || To treat Chagas disease in certain pediatric patients younger than age 18 | |||
|- | |||
| 31 || Blenrep || belantamab mafodotin-blmf || 8/5/2020 || To treat multiple myeloma | |||
|- | |||
| 30 || Monjuvi || tafasitamab-cxix || 7/31/2020 || To treat relapsed or refractory diffuse large B-cell lymphoma | |||
|- | |||
| 29 || Xeglyze || abametapir || 7/24/2020 || To treat head lice | |||
|- | |||
| 28 || Inqovi || decitabine and cedazuridine || 7/7/2020 || To treat adult patients with myelodysplastic syndromes | |||
|- | |||
| 27 || Rukobia || fostemsavir || 7/2/2020 || To treat HIV | |||
|- | |||
| 26 || Byfavo || remimazolam || 7/2/2020 || For sedation | |||
|- | |||
| 25 || Dojolvi || triheptanoin || 6/30/2020 || To treat molecularly long-chain fatty acid oxidation disorders | |||
|- | |||
| 24 || Zepzelca || lurbinectedin || 6/15/2020 || To treat metastatic small cell lung cancer | |||
|- | |||
| 23 || Uplizna || inebilizumab-cdon || 6/11/2020 || To treat neuromyelitis optica spectrum disorder | |||
|- | |||
| 22 || Tauvid || flortaucipir F18 || 5/28/2020 || Diagnostic agent for patients with Alzheimer’s disease | |||
|- | |||
| 21 || Artesunate || artesunate || 5/26/2020 || To treat severe malaria | |||
|- | |||
| 20 || Cerianna || fluoroestradiol F18 || 5/20/2020 || Diagnostic imaging agent for certain patients with breast cancer | |||
|- | |||
| 19 || Qinlock || ripretinib || 5/15/2020 || To treat advanced gastrointestinal-stromal tumors | |||
|- | |||
| 18 || Retevmo || selpercatinib || 5/8/2020 || To treat lung and thyroid cancers | |||
|- | |||
| 17 || Tabrecta || capmatinib || 5/6/2020 || To treat patients with non small cell lung cancer | |||
|- | |||
| 16 || Ongentys || opicapone || 4/24/2020 || To treat patients with Parkinson’s disease experiencing “off” episodes | |||
|- | |||
| 15 || Trodelvy || sacituzumab govitecan-hziy || 4/22/2020 || To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease | |||
|- | |||
| 14 || Pemazyre || pemigatinib || 4/17/2020 || To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts | |||
|- | |||
| 13 || Tukysa || tucatinib || 4/17/2020 || To treat advanced unresectable or metastatic HER2-positive breast cancer | |||
|- | |||
| 12 || Koselugo || selumetinib || 4/10/2020 || To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves | |||
|- | |||
| 11 || Zeposia || ozanimod || 3/25/2020 || To treat relapsing forms of multiple sclerosis | |||
|- | |||
| 10 || Isturisa || osilodrostat || 3/6/2020 || To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease | |||
|- | |||
| 9 || Sarclisa || isatuximab || 3/2/2020 || To treat multiple myloma | |||
|- | |||
| 8 || Nurtec ODT || rimegepant || 2/27/2020 || To treat migraine | |||
|- | |||
| 7 || Barhemsys || amisulpride || 2/26/2020 || To help prevent nausea and vomiting after surgery | |||
|- | |||
| 6 || Vyepti || eptinezumab-jjmr || 2/21/2020 || For the preventive treatment of migraine in adults | |||
|- | |||
| 5 || Nexletol || bempedoic acid || 2/21/2020 || To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C | |||
|- | |||
| 4 || Pizensy || lactitol || 2/12/2020 || To treat chronic idiopathic constipation (CIC) in adults | |||
|- | |||
| 3 || Tazverik || tazemetostat || 1/23/2020 || To treat epithelioid sarcoma | |||
|- | |||
| 2 || Tepezza || teprotumumab-trbw || 1/21/2020 || To treat Thyroid eye disease | |||
|- | |||
| 1 || Ayvakit || avapritinib || 1/9/2020 || To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) | |||
|} | |||
===Novel Drug Approvals for 2019=== | |||
{| class="wikitable" | |||
! No. !! Drug Name !! Active Ingredient !! Approval Date !! FDA-approved use on approval date | |||
|- | |||
| 48 || Ubrelvy || ubrogepant || 12/23/2019 || to treat acute treatment of migraine with or without aura in adults | |||
|- | |||
| 47 || Enhertu || fam-trastuzumab deruxtecan-nxki || 12/20/2019 || To treat metastatic breast cancer | |||
|- | |||
| 46 || Dayvigo || lemborexant || 12/20/2019 || To treat insomnia | |||
|- | |||
| 45 || Caplyta || lumateperone tosylate || 12/20/2019 || To treat schizophrenia | |||
|- | |||
| 44 || TissueBlue || Brilliant Blue G Ophthalmic Solution || 12/20/2019 || Dye used in eye surgery | |||
|- | |||
| 43 || Padcev || enfortumab vedotin-ejfv || 12/18/2019 || To treat refractory bladder cancer | |||
|- | |||
| 42 || Vyondys 53 || golodirsen || 12/12/2019 || To treat certain patients with Duchenne muscular dystrophy | |||
|- | |||
| 41 || Oxbryta || voxelotor || 11/25/2019 || To treat sickle cell disease | |||
|- | |||
| 40 || Xcopri || cenobamate || 11/21/2019 || To treat partial onset seizures | |||
|- | |||
| 39 || Givlaari || givosiran || 11/20/2019 || To treat acute hepatic porphyria, a rare blood disorder | |||
|- | |||
| 38 || Adakveo || crizanlizumab-tmca || 11/15/2019 || To treat patients with painful complication of sickle cell disease | |||
|- | |||
| 37 || Fetroja || cefiderocol || 11/14/2019 || To treat patients with complicated urinary tract infections who have limited or no alternative treatment options | |||
|- | |||
| 36 || Brukinsa || zanubrutinib || 11/14/2019 || To treat certain patients with mantle cell lymphoma, a form of blood cancer | |||
|- | |||
| 35 || Reblozyl || luspatercept–aamt || 11/8/2019 || For the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions | |||
|- | |||
| 34 || ExEm Foam || air polymer-type A || 11/7/2019 || A diagnostic agent used to assess fallopian tube patency (openness) in women with known or suspected infertility | |||
|- | |||
| 33 || Trikafta || elexacaftor/ivacaftor/tezacaftor || 10/21/2019 || To treat patients 12 years of age and older with the most common gene mutation that causes cystic fibrosis | |||
|- | |||
| 32 || Reyvow || lasmiditan || 10/11/2019 || For the acute treatment of migraine with or without aura, in adults | |||
|- | |||
| 31 || || fluorodopa F 18 || 10/10/2019 || A diagnostic agent for use in positron emission tomography (PET) to help diagnose adult patients with suspected Parkinsonian syndromes (PS) | |||
|- | |||
| 30 || Scenesse || afamelanotide || 10/8/2019 || To increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria | |||
|- | |||
| 29 || Beovu || brolucizumab–dbll || 10/7/2019 || Treatment of wet age-related macular degeneration | |||
|- | |||
| 28 || Aklief || trifarotene || 10/4/2019 || For the topical treatment of acne vulgaris in patients 9 years of age and older | |||
|- | |||
| 27 || Ibsrela || tenapanor || 9/12/2019 || To treat irritable bowel syndrome with constipation in adults. | |||
|- | |||
| 26 || Nourianz || istradefylline || 8/27/2019 || To treat adult patients with Parkinson’s disease experiencing “off” episodes | |||
|- | |||
| 25 || Ga-68-DOTATOC || Ga-68-DOTATOC || 8/21/2019 || For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) | |||
|- | |||
| 24 || Xenleta || lefamulin || 8/19/2019 || To treat adults with community-acquired bacterial pneumonia | |||
|- | |||
| 23 || Rinvoq || upadacitinib || 8/16/2019 || To treat adults with moderately to severely active rheumatoid arthritis | |||
|- | |||
| 22 || Inrebic || fedratinib || 8/16/2019 || To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis | |||
|- | |||
| 21 || Rozlytrek || entrectinib || 8/15/2019 || To treat adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive | |||
|- | |||
| 20 || Wakix || pitolisant || 8/14/2019 || To treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy | |||
|- | |||
| 19 || || pretomanid || 8/14/2019 || For treatment-resistant forms of tuberculosis that affects the lungs | |||
|- | |||
| 18 || Turalio || pexidartinib || 8/2/2019 || To treat adult patients with symptomatic tenosynovial giant cell tumor | |||
|- | |||
| 17 || Nubeqa || darolutamide || 7/30/2019 || To treat adult patients with non-metastatic castration resistant prostate cancer | |||
|- | |||
| 16 || Accrufer || ferric maltol || 7/25/2019 || To treat iron deficiency anemia in adults | |||
|- | |||
| 15 || Recarbrio || imipenem, cilastatin and relebactam || 7/16/2019 || To treat complicated urinary tract and complicated intra-abdominal infections | |||
|- | |||
| 14 || Xpovio || selinexor || 7/3/2019 || To treat adult patients with relapsed or refractory multiple myeloma (RRMM) | |||
|- | |||
| 13 || Vyleesi || bremelanotide || 6/21/2018 || To treat hypoactive sexual desire disorder in premenopausal women. | |||
|- | |||
| 12 || Polivy || polatuzumab vedotin-piiq || 6/10/2019 || To treat adult patients with relapsed or refractory diffuse large B-cell lymphoma | |||
|- | |||
| 11 || Piqray || alpelisib || 5/24/2019 || To treat breast cancer | |||
|- | |||
| 10 || Vyndaqel || tafamidis meglumine || 5/3/2019 || To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults | |||
|- | |||
| 9 || Skyrizi || risankizumab-rzaa || 4/23/2019 || To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy | |||
|- | |||
| 8 || Balversa || erdafitinib || 4/12/2019 || To treat adult patients with locally advanced or metastatic bladder cancer | |||
|- | |||
| 7 || Evenity || romosozumab-aqqg || 4/9/2019 || To treat osteoporosis in postmenopausal women at high risk of fracture | |||
|- | |||
| 6 || Mayzent || siponimod || 3/26/2019 || To treat adults with relapsing forms of multiple sclerosis | |||
|- | |||
| 5 || Sunosi || solriamfetol || 3/20/2019 || To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea | |||
|- | |||
| 4 || Zulresso || brexanolone || 3/19/2019 || To treat postpartum depression (PPD) in adult women | |||
|- | |||
| 3 || Egaten || triclabendazole || 2/13/2019 || To treat fascioliasis, a parasitic infestation caused by two species of flatworms or trematodes that mainly the affect the liver, sometimes referred to as “liver flukes” | |||
|- | |||
| 2 || Cablivi || caplacizumab-yhdp || 2/6/2019 || To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) | |||
|- | |||
| 1 || Jeuveau || prabotulinumtoxinA-xvfs || 2/1/2019 || For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients | |||
|} | |||
<!--- | |||
{| class="wikitable" | |||
| align="center" style="background:#f0f0f0;" |'''Year''' | |||
| align="center" style="background:#f0f0f0;" |'''No.''' | |||
| align="center" style="background:#f0f0f0;" |'''Brand Name''' | |||
| align="center" style="background:#f0f0f0;" |'''Active Ingredient''' | |||
| align="center" style="background:#f0f0f0;" |'''Page Link''' | |||
| align="center" style="background:#f0f0f0;" |'''DailyMed Search''' | |||
| align="center" style="background:#f0f0f0;" |'''Approval Date''' | |||
| align="center" style="background:#f0f0f0;" |'''Status''' | |||
| align="center" style="background:#f0f0f0;" |'''Author''' | |||
|- | |||
|2019||12||Polivy||Polatuzumab vedotin-piiq||[[Polatuzumab vedotin-piiq]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Polivy Polivy]||6/10/2019 | |||
| | |||
| | |||
|- | |||
|2019||11||Piqray||Alpelisib||[[Alpelisib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Piqray Piqray]||5/24/2019 | |||
|Needs review | |||
|Uma Maveli | |||
|- | |||
|2019||10||Vyndaqel||Tafamidis meglumine||[[Tafamidis meglumine]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Vyndaqel Vyndaqel]||5/3/2019 | |||
| | |||
| | |||
|- | |||
|2019||9||Skyrizi||Risankizumab||[[Risankizumab]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Skyrizi Skyrizi]||4/23/2019 | |||
| | |||
| | |||
|- | |||
|2019||8||Balversa||Erdafitinib||[[Erdafitinib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Balversa Balversa]||4/12/2019 | |||
| | |||
| | |||
|- | |||
|2019||7||Evenity||Romosozumab||[[Romosozumab]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Evenity Evenity]||4/9/2019 | |||
| | |||
| | |||
|- | |||
|2019||6||Mayzent||Siponimod||[[Siponimod]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Mayzent Mayzent]||3/26/2019 | |||
| | |||
| | |||
|- | |||
|2019||5||Sunosi||Solriamfetol||[[Solriamfetol]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Sunosi Sunosi]||3/20/2019 | |||
| | |||
| | |||
|- | |||
|2019||4||Zulresso||Brexanolone||[[Brexanolone]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Zulresso Zulresso]||3/19/2019 | |||
| | |||
| | |||
|- | |||
|2019||3||Egaten||Triclabendazole||[[Triclabendazole]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Egaten Egaten]||2/13/2019 | |||
| | |||
| | |||
|- | |||
|2019||2||Cablivi||Caplacizumab||[[Caplacizumab]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Cablivi Cablivi]||2/6/2019 | |||
| | |||
| | |||
|- | |||
|2019||1||Jeuveau||prabotulinum toxin type a powder||[[prabotulinum toxin type a powder]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Jeuveau Jeuveau]||2/1/2019 | |||
| | |||
| | |||
|- | |||
|2018||59||Ultomiris||Ravulizumab||[[Ravulizumab]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Ultomiris Ultomiris]||12/21/2018 | |||
|Needs review | |||
|Bhavya | |||
|- | |||
|2018||58||Elzonris||Tagraxofusp-erzs||[[Tagraxofusp-erzs]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Elzonris Elzonris]||12/21/2018 | |||
| | |||
| | |||
|- | |||
|2018||57||Asparlas||Calaspargase pegol-mknl||[[Calaspargase pegol-mknl]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Asparlas Asparlas]||12/20/2018 | |||
| | |||
| | |||
|- | |||
|2018||56||Motegrity||Prucalopride||[[Prucalopride]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Motegrity Motegrity]||12/14/2018 | |||
| | |||
| | |||
|- | |||
|2018||55||Xospata||Gilteritinib||[[Gilteritinib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Xospata Xospata]||11/28/2018 | |||
|Needs review | |||
|Uma Maveli | |||
|- | |||
|2018||54||Firdapse||Amifampridine||[[Amifampridine]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Firdapse Firdapse]||11/28/2028 | |||
| | |||
| | |||
|- | |||
|2018||53||Vitrakvi||Larotrectinib||[[Larotrectinib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Vitrakvi Vitrakvi]||11/26/2018 | |||
| | |||
| | |||
|- | |||
|2018||52||Daurismo||Glasdegib||[[Glasdegib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Daurismo Daurismo]||11/21/2018 | |||
|Need review | |||
|Bhavya | |||
|- | |||
|2018||51||Gamifant||Emapalumab-lzsgemapalumab-lzsg||[[Emapalumab-lzsgemapalumab-lzsg]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Gamifant Gamifant]||11/20/2018 | |||
| | |||
| | |||
|- | |||
|2018||50||Aemcolo||Rifamycin||[[Rifamycin]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Aemcolo Aemcolo]||11/16/2018 | |||
| | |||
| | |||
|- | |||
|2018||49||Yupelri||Revefenacin||[[Revefenacin]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Yupelri Yupelri]||11/9/2018 | |||
|Needs review | |||
|Uma Maveli | |||
|- | |||
|2018||48||Lorbrena||Lorlatinib||[[Lorlatinib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Lorbrena Lorbrena]||11/2/2018 | |||
|Needs review | |||
|Uma Maveli | |||
|- | |||
|2018||47||Xofluza||Baloxavir marboxil||[[Baloxavir marboxil]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Xofluza Xofluza]||10/24/2018 | |||
| | |||
| | |||
|- | |||
|2018||46||Talzenna||Talazoparib||[[Talazoparib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Talzenna Talzenna]||10/16/2018 | |||
| | |||
| | |||
|- | |||
|2018||45||Tegsedi||Inotersen||[[Inotersen]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Tegsedi Tegsedi]||10/5/2018 | |||
| | |||
| | |||
|- | |||
|2018||44||Revcovi||Elapegademase-lvlr||[[Elapegademase-lvlr]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Revcovi Revcovi]||10/5/2018 | |||
| | |||
| | |||
|- | |||
|2018||43||Nuzyra||Omadacycline||[[Omadacycline]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Nuzyra Nuzyra]||10/2/2018 | |||
| | |||
| | |||
|- | |||
|2018||42||Seysara||Sarecycline||[[Sarecycline]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Seysara Seysara]||10/1/2018 | |||
| | |||
| | |||
|- | |||
|2018||41||Libtayo||Cemiplimab-rwlc||[[Cemiplimab-rwlc]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Libtayo Libtayo]||9/28/2018 | |||
| | |||
| | |||
|- | |||
|2018||40||Vizimpro||Dacomitinib||[[Dacomitinib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Vizimpro Vizimpro]||9/27/2018 | |||
| | |||
| | |||
|- | |||
|2018||39||Emgality||Galcanezumab-gnlm||[[Galcanezumab-gnlm]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Emgality Emgality]||9/27/2018 | |||
| | |||
| | |||
|- | |||
|2018||38||Copiktra||Duvelisib||[[Duvelisib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Copiktra Copiktra]||9/24/2018 | |||
| | |||
| | |||
|- | |||
|2018||37||Ajovy||Fremanezumab-vfrm||[[Fremanezumab-vfrm]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Ajovy Ajovy]||9/14/2018 | |||
| | |||
| | |||
|- | |||
|2018||36||Lumoxiti||Moxetumomab pasudotox-tdfk||[[Moxetumomab pasudotox-tdfk]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Lumoxiti Lumoxiti]||9/13/2018 | |||
| | |||
| | |||
|- | |||
|2018||35||Pifeltro||Doravirine||[[Doravirine]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Pifeltro Pifeltro]||8/30/2018 | |||
| | |||
| | |||
|- | |||
|2018||34||Xerava||Eravacycline||[[Eravacycline]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Xerava Xerava]||8/27/2018 | |||
| | |||
| | |||
|- | |||
|2018||33||Takhzyro||Lanadelumab||[[Lanadelumab]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Takhzyro Takhzyro]||8/23/2018 | |||
| | |||
| | |||
|- | |||
|2018||32||Oxervate||Cenegermin-bkbj||[[Cenegermin-bkbj]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Oxervate Oxervate]||8/22/2018 | |||
| | |||
| | |||
|- | |||
|2018||31||Diacomit||Stiripentol||[[Stiripentol]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Diacomit Diacomit]||8/20/2018 | |||
| | |||
| | |||
|- | |||
|2018||30||Galafold||Migalastat||[[Migalastat]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Galafold Galafold]||8/10/2018 | |||
| | |||
| | |||
|- | |||
|2018||29||Annovera||Segesterone acetate and ethinyl estradiol vaginal system||[[Segesterone acetate and ethinyl estradiol vaginal system]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Annovera Annovera]||8/10/2018 | |||
| | |||
| | |||
|- | |||
|2018||28||Onpattro||Patisiran||[[Patisiran]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Onpattro Onpattro]||8/10/2018 | |||
| | |||
| | |||
|- | |||
|2018||27||Poteligeo||Mogamulizumab||[[Mogamulizumab]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Poteligeo Poteligeo]||8/8/2018 | |||
| | |||
| | |||
|- | |||
|2018||26||Mulpleta||Lusutrombopag||[[Lusutrombopag]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Mulpleta Mulpleta]||7/31/2018 | |||
| | |||
| | |||
|- | |||
|2018||25||Omegaven||Fish oil triglycerides||[[Fish oil triglycerides]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Omegaven Omegaven]||7/27/2018 | |||
|Bhavya | |||
|In progress | |||
|- | |||
|2018||24||Orilissa||Elagolix||[[Elagolix]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Orilissa Orilissa]||7/23/2018 | |||
| | |||
| | |||
|- | |||
|2018||23||Krintafel||Tafenoquine||[[Tafenoquine]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Krintafel Krintafel]||7/20/2018 | |||
| | |||
| | |||
|- | |||
|2018||22||Tibsovo||Ivosidenib||[[Ivosidenib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Tibsovo Tibsovo]||7/20/2018 | |||
| | |||
| | |||
|- | |||
|2018||21||TPOXX||Tecovirimat||[[Tecovirimat]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=TPOXX TPOXX]||7/13/2018 | |||
| | |||
| | |||
|- | |||
|2018||20||Braftovi||Encorafenib||[[Encorafenib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Braftovi Braftovi]||6/27/2018 | |||
| | |||
| | |||
|- | |||
|2018||19||Mektovi||Binimetinib||[[Binimetinib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Mektovi Mektovi]||6/27/2018 | |||
| | |||
| | |||
|- | |||
|2018||18||Zemdri||Plazomicin||[[Plazomicin]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Zemdri Zemdri]||6/25/2018 | |||
| | |||
| | |||
|- | |||
|2018||17||Epidioloex||Cannabidiol||[[Cannabidiol]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Epidioloex Epidioloex]||6/25/2018 | |||
| | |||
| | |||
|- | |- | ||
| 2018||16||Moxidectin||Moxidectin||[[Moxidectin]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Moxidectin Moxidectin]||6/13/2018 | |2018||16||Moxidectin||Moxidectin||[[Moxidectin]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Moxidectin Moxidectin]||6/13/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||15||Olumiant||Baricitinib||[[Baricitinib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Olumiant Olumiant]||5/31/2018 | |2018||15||Olumiant||Baricitinib||[[Baricitinib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Olumiant Olumiant]||5/31/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||14||Palynziq||Pegvaliase-pqpz||[[Pegvaliase-pqpz]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Palynziq Palynziq]||5/24/2018 | |2018||14||Palynziq||Pegvaliase-pqpz||[[Pegvaliase-pqpz]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Palynziq Palynziq]||5/24/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||13||Doptelet||Avatrombopag||[[Avatrombopag]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Doptelet Doptelet]||5/21/2018 | |2018||13||Doptelet||Avatrombopag||[[Avatrombopag]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Doptelet Doptelet]||5/21/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||12||Lokelma||Sodium zirconium cyclosilicate||[[Sodium zirconium cyclosilicate]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Lokelma Lokelma]||5/18/2018 | |2018||12||Lokelma||Sodium zirconium cyclosilicate||[[Sodium zirconium cyclosilicate]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Lokelma Lokelma]||5/18/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||11||Aimovig||Erenumab-aooe||[[Erenumab-aooe]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Aimovig Aimovig]||5/17/2018 | |2018||11||Aimovig||Erenumab-aooe||[[Erenumab-aooe]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Aimovig Aimovig]||5/17/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||10||Lucemyra||Lofexidine hydrochloride||[[Lofexidine hydrochloride]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Lucemyra Lucemyra]||5/16/2018 | |2018||10||Lucemyra||Lofexidine hydrochloride||[[Lofexidine hydrochloride]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Lucemyra Lucemyra]||5/16/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||9||Akynzeo||Fosnetupitant and palonosetron||[[Fosnetupitant and palonosetron]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Akynzeo Akynzeo]||4/19/2018 | |2018||9||Akynzeo||Fosnetupitant and palonosetron||[[Fosnetupitant and palonosetron]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Akynzeo Akynzeo]||4/19/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||8||Crysvita||Burosumab-twza||[[Burosumab-twza]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Crysvita Crysvita]||4/17/2018 | |2018||8||Crysvita||Burosumab-twza||[[Burosumab-twza]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Crysvita Crysvita]||4/17/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||7||Tavalisse||Fostamatinib||[[Fostamatinib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Tavalisse Tavalisse]||4/17/2018 | |2018||7||Tavalisse||Fostamatinib||[[Fostamatinib]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Tavalisse Tavalisse]||4/17/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||6||Ilumya||Tildrakizumab||[[Tildrakizumab]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Ilumya Ilumya]||3/20/2018 | |2018||6||Ilumya||Tildrakizumab||[[Tildrakizumab]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Ilumya Ilumya]||3/20/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||5||Trogarzo||Ibalizumab-uiyk||[[Ibalizumab-uiyk]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Trogarzo Trogarzo]||3/6/2018 | |2018||5||Trogarzo||Ibalizumab-uiyk||[[Ibalizumab-uiyk]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Trogarzo Trogarzo]||3/6/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||4||Erleada||Apalutamide||[[Apalutamide]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Erleada Erleada]||2/14/2018 | |2018||4||Erleada||Apalutamide||[[Apalutamide]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Erleada Erleada]||2/14/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||3||Symdeko||Tezacaftor | |2018||3||Symdeko||Tezacaftor/ivacaftor||[[Tezacaftor/ivacaftor]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Symdeko Symdeko]||2/12/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||2||Biktarvy||Bictegravir sodium, | |2018||2||Biktarvy||Bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate||[[Bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Biktarvy Biktarvy]||2/7/2018 | ||
| | |||
| | |||
|- | |- | ||
| 2018||1||Lutathera||Lutetium lu 177 dotatate||[[Lutetium lu 177 dotatate]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Lutathera Lutathera]||1/26/2018 | |2018||1||Lutathera||Lutetium lu 177 dotatate||[[Lutetium lu 177 dotatate]]||[https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Lutathera Lutathera]||1/26/2018 | ||
| | |||
| | |||
|} | |} | ||
---> | |||
</div> | </div> | ||
Latest revision as of 04:30, 22 February 2024
WikiDoc Drug Project — High-Priority Medications
- Template here: Drug page template
- Example here: Clopidogrel
- FDA package insert here: DailyMed
List of high-priority medications
Novel Drug Approvals for 2023
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 55 | Wainua | eplontersen | 12/21/2023 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| 54 | Filsuvez | birch triterpenes | 12/18/2023 | To treat wounds associated with dystrophic and junctional epidermolysis bullosa |
| 53 | Fabhalta | iptacopan | 12/5/2023 | To treat paroxysmal nocturnal hemoglobinuria |
| 52 | Ogsiveo | nirogacestat | 11/27/2023 | To treat adults with progressing desmoid tumors who require systemic treatment |
| 51 | Truqap | capivasertib | 11/16/2023 | To treat breast cancer that meets certain disease criteria |
| 50 | Ryzneuta | efbemalenograstim alfa-vuxw | 11/16/2023 | To treat neutropenia |
| 49 | Augtyro | repotrectinib | 11/15/2023 | To treat ROS1-positive non-small cell lung cancer |
| 48 | Defencath | taurolidine, heparin | 11/15/2023 | To reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter |
| 47 | Fruzaqla | fruquintinib | 11/08/23 | To treat refractory, metastatic colorectal cancer |
| 46 | Loqtorzi | toripalimab-tpzi | 10/27/2023 | To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies |
| 45 | Omvoh | mirikizumab-mrkz | 10/26/2023 | To treat ulcerative colitis |
| 44 | Agamree | vamorolone | 10/26/2023 | To treat Duchenne muscular dystrophy |
| 43 | Bimzelx | bimekizumab | 10/17/2023 | To treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy |
| 42 | Zilbrysq | zilucoplan | 10/17/2023 | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive |
| 41 | Velsipity | etrasimod | 10/12/23 | To treat moderately to severely active ulcerative colitis in adults |
| 40 | Rivfloza | nedosiran | 9/29/2023 | To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function |
| 39 | Pombiliti | cipaglucosidase alfa-atga | 9/28/2023 | To treat late-onset Pompe disease |
| 38 | Exxua | gepirone | 9/22/2023 | To treat major depressive disorder |
| 37 | Ojjaara | momelotinib | 9/15/2023 | To treat intermediate or high-risk myelofibrosis in adults with anemia |
| 36 | Aphexda | motixafortide | 09/08/23 | To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma |
| 35 | Veopoz | pozelimab-bbfg | 8/18/2023 | To treat patients 1 year old and older with CD55-deficient protein-losing enteropathy (PLE), also known as CHAPLE disease |
| 34 | Sohonos | palovarotene | 8/16/2023 | To reduce the volume of new heterotopic ossification in adults and pediatric patients (aged 8 years and older for females and 10 years and older for males) with fibrodysplasia ossificans progressiva |
| 33 | Elrexfio | elranatamab-bcmm | 8/14/2023 | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy |
| 32 | Talvey | talquetamab-tgvs | 08/09/23 | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies |
| 31 | Izervay | avacincaptad pegol | 08/04/23 | To treat geographic atrophy secondary to age-related macular degeneration |
| 30 | Zurzuvae | zuranolone | 08/04/23 | To treat postpartum depression |
| 29 | Xdemvy | lotilaner | 7/25/2023 | To treat Demodex blepharitis |
| 28 | Vanflyta | quizartinib | 7/20/2023 | To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria |
| 27 | Beyfortus | nirsevimab-alip | 7/17/2023 | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease |
| 26 | Ngenla | somatrogon-ghla | 6/27/2023 | To treat growth failure due to inadequate secretion of endogenous growth hormone |
| 25 | Rystiggo | rozanolixizumab-noli | 6/26/2023 | To treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive |
| 24 | Litfulo | ritlecitinib | 6/23/2023 | To treat severely patchy hair loss |
| 23 | Columvi | glofitamab-gxbm | 6/15/2023 | To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy |
| 22 | Inpefa | sotagliflozin | 5/26/2023 | To treat heart failure |
| 21 | Posluma | flotufolastat F 18 | 5/25/2023 | To use with positron emission tomography imaging in certain patients with prostate cancer |
| 20 | Paxlovid | nirmatrelvir, ritonavir | 5/25/2023 | To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19 |
| 19 | Xacduro | sulbactam, durlobactam | 5/23/2023 | To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex |
| 18 | Epkinly | epcoritamab-bysp | 5/19/2023 | To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy |
| 17 | Miebo | perfluorhexyloctane | 5/18/2023 | To treat signs and symptoms of dry eye disease |
| 16 | Veozah | fezolinetant | 05/12/23 | To treat moderate to severe hot flashes caused by menopause |
| 15 | Elfabrio | pegunigalsidase alfa-iwxj | 05/09/23 | To treat confirmed Fabry disease |
| 14 | Qalsody | tofersen | 4/25/2023 | To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation |
| 13 | Joenja | leniolisib | 3/24/2023 | To treat activated phosphoinositide 3-kinase delta syndrome |
| 12 | Rezzayo | rezafungin | 3/22/2023 | To treat candidemia and invasive candidiasis |
| 11 | Zynyz | retifanlimab-dlwr | 3/22/2023 | To treat metastatic or recurrent locally advanced Merkel cell carcinoma |
| 10 | Daybue | trofinetide | 03/10/23 | To treat Rett syndrome |
| 9 | Zavzpret | zavegepant | 03/09/23 | To treat migraine |
| 8 | Skyclarys | omaveloxolone | 2/28/2023 | To treat Friedrich’s ataxia |
| 7 | Filspari | sparsentan | 2/17/2023 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression |
| 6 | Lamzede | velmanase alfa-tycv | 2/16/2023 | To treat non-central nervous system manifestations of alpha-mannosidosis |
| 5 | Jesduvroq | daprodustat | 02/01/23 | To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months |
| 4 | Orserdu | elacestrant | 1/27/2023 | To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy |
| 3 | Jaypirca | pirtobrutinib | 1/27/2023 | To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor |
| 2 | Brenzavvy | bexagliflozin | 1/20/2023 | To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise |
| 1 | Leqembi | lecanemab-irmb | 01/06/23 | To treat Alzheimer’s disease |
Novel Drug Approvals for 2022
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 37 | NexoBrid | anacaulase-bcdb | 12/28/2022 | To remove eschar in adults with deep partial thickness or full thickness thermal burns |
| 36 | Briumvi | ublituximab-xiiy | 12/28/2022 | To treat relapsing forms of multiple sclerosis |
| 35 | Xenoview | hyperpolarized Xe-129 | 12/23/2022 | To evaluate pulmonary function and imaging |
| 34 | Lunsumio | mosunetuzumab-axgb | 12/22/2022 | To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma |
| 33 | Sunlenca | lenacapavir | 12/22/2022 | To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerationsPress Release |
| 32 | Krazati | adagrasib | 12/12/2022 | To treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy |
| 31 | Rezlidhia | olutasidenib | 12/1/2022 | To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation |
| 30 | Tzield | teplizumab-mzwv | 11/18/22 | To delay the onset of stage 3 type 1 diabetesPress Release |
| 29 | Elahere | mirvetuximab soravtansine-gynx | 11/14/2022 | To treat patients with recurrent ovarian cancer that is resistant to platinum therapy |
| 28 | Tecvayli | teclistamab-cqyv | 10/25/2022 | To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy |
| 27 | Imjudo | tremelimumab | 10/21/2022 | To treat unresectable hepatocellular carcinoma |
| 26 | Lytgobi | futibatinib | 9/30/2022 | To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements |
| 25 | Relyvrio | sodium phenylbutyrate/taurursodiol | 9/29/2022 | To treat amyotrophic lateral sclerosis (ALS)Press Release |
| 24 | Omlonti | oomidenepag isopropyl ophthalmic solution | 9/22/2022 | To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension |
| 23 | Elucirem | gadopiclenol | 9/21/2022 | To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body |
| 22 | Terlivaz | terlipressin | 9/14/2022 | To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function |
| 21 | Rolvedon | eflapegrastim | 9/9/2022 | To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia |
| 20 | Sotyktu | deucravacitinib | 9/9/2022 | To treat moderate-to-severe plaque psoriasis |
| 19 | Daxxify | daxibotulinumtoixnA-lanm | 9/7/2022 | To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity |
| 18 | Spevigo | spesolimab-sbzo | 9/1/2022 | To treat generalized pustular psoriasis flares |
| 17 | Xenpozyme | Olipudase alfa | 8/31/2022 | To treat Acid Sphingomyelinase DeficiencyPress Release |
| 16 | Amvuttra | vutrisiran | 6/13/2022 | To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis |
| 15 | Vtama | tapinarof | 5/23/2022 | To treat plaque psoriasis |
| 14 | Mounjaro | tirzepatide | 5/13/2022 | To improve blood sugar control in diabetes, in addition to diet and exercise Press Release |
| 13 | Voquezna | vonoprazan, amoxicillin, and clarithromycin | 5/3/2022 | To treat Helicobacter pylori infection |
| 12 | Camzyos | mavacamten | 4/28/2022 | To treat certain classes of obstructive hypertrophic cardiomyopathy |
| 11 | Vivjoa | oteseconazole | 4/26/2022 | To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential |
| 10 | Pluvicto | lutetium (177Lu) vipivotide tetraxetan | 3/23/2022 | To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies |
| 9 | Opdualag | nivolumab and relatlimab-rmbw | 3/18/2022 | To treat unresectable or metastatic melanoma |
| 8 | Ztalmy | ganaxolone | 3/18/2022 | To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder |
| 7 | Vonjo | pacritinib | 2/28/2022 | To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets |
| 6 | Pyrukynd | mitapivat | 2/17/2022 | To treat hemolytic anemia in pyruvate kinase deficiency |
| 5 | Enjaymo | sutimlimab-jome | 2/4/2022 | To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease |
| 4 | Vabysmo | faricimab-svoa | 1/28/2022 | To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema |
| 3 | Kimmtrak | tebentafusp-tebn | 1/25/2022 | To treat unresectable or metastatic uveal melanoma |
| 2 | Cibinqo | abrocitinib | 1/14/2022 | To treat refractory, moderate-to-severe atopic dermatitis |
| 1 | Quviviq | daridorexant | 1/7/2022 | To treat insomnia |
Novel Drug Approvals for 2021
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 42 | Scemblix | asciminib | 10/29/2021 | To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria |
| 41 | Tavneos | avacopan | 10/7/2021 | To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including glucocorticoids |
| 40 | Livmarli | maralixibat | 9/29/2021 | To treat cholestatic pruritus associated with Alagille syndrome |
| 39 | Qulipta | atogepant | 9/28/2021 | To prevent episodic migraines |
| 38 | Tivdak | tisotumab vedotin-tftv | 9/20/2021 | To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy |
| 37 | Exkivity | mobocertinib | 9/15/2021 | To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations |
| 36 | Skytrofa | lonapegsomatropin-tcgd | 8/25/2021 | To treat short stature due to inadequate secretion of endogenous growth hormone |
| 35 | Korsuva | difelikefalin | 8/23/2021 | To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations |
| 34 | Welireg | belzutifan | 8/13/2021 | To treat von Hippel-Lindau disease under certain conditions |
| 33 | Nexviazyme | avalglucosidase alfa-ngpt | 8/6/2021 | To treat late-onset Pompe disease |
| 32 | Saphnelo | anifrolumab-fnia | 7/30/2021 | To treat moderate-to severe systemic lupus erythematousus along with standard therapy |
| 31 | Bylvay | odevixibat | 7/20/2021 | To treat pruritus |
| 30 | Rezurock | belumosudil | 7/16/2021 | To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy |
| 29 | fexinidazole | fexinidazole | 7/16/2021 | To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense |
| 28 | Kerendia | finerenone | 7/9/2021 | To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes |
| 27 | Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | 6/30/2021 | To treat acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products, as a component of a chemotherapy regimen |
| 26 | Aduhelm | aducanumab-avwa | 6/7/2021 | To treat Alzheimer’s disease |
| 25 | Brexafemme | ibrexafungerp | 6/1/2021 | To treat vulvovaginal candidiasis |
| 24 | Lybalvi | olanzapine and samidorphan | 5/28/2021 | To treat schizophrenia and certain aspects of bipolar I disorder |
| 23 | Truseltiq | infigratinib | 5/28/2021 | To treat cholangiocarcinoma whose disease meets certain criteria |
| 22 | Lumakras | sotorasib | 5/28/2021 | To treat types of non-small cell lung cancer |
| 21 | Pylarify | piflufolastat F 18 | 5/26/2021 | To identify prostate-specific membrane antigen-positive lesions in prostate cancer |
| 20 | Rybrevant | amivantamab-vmjw | 5/21/2021 | To treat a subset of non-small cell lung cancer |
| 19 | Empaveli | pegcetacoplan | 5/14/2021 | To treat paroxysmal nocturnal hemoglobinuria |
| 18 | Zynlonta | loncastuximab tesirine-lpyl | 4/23/2021 | To treat certain types of relapsed or refractory large B-cell lymphoma |
| 17 | Jemperli | dostarlimab-gxly | 4/22/2021 | To treat endometrial cancer |
| 16 | Nextstellis | drospirenone and estetrol | 4/15/2021 | To prevent pregnancy |
| 15 | Qelbree | viloxazine | 4/2/2021 | To treat attention deficit hyperactivity disorder |
| 14 | Zegalogue | dasiglucagon | 3/22/2021 | To treat severe hypoglycemia |
| 13 | Ponvory | ponesimod | 3/18/2021 | To treat relapsing forms of multiple sclerosis |
| 12 | Fotivda | tivozanib | 3/10/2021 | To treat renal cell carcinoma |
| 11 | Azstarys | serdexmethylphenidate and dexmethylphenidate | 3/2/2021 | To treat attention deficit hyperactivity disorder |
| 10 | Pepaxto | melphalan flufenamide | 2/26/2021 | To treat relapsed or refractory multiple myeloma |
| 9 | Nulibry | fosdenopterin | 2/26/2021 | To reduce the risk of mortality in molybdenum cofactor deficiency Type A |
| 8 | Amondys 45 | casimersen | 2/25/2021 | To treat Duchenne muscular dystrophy |
| 7 | Cosela | trilacicilib | 2/12/2021 | To mitigate chemotherapy-induced myelosuppression in small cell lung cancer |
| 6 | Evkeeza | evinacumab-dgnb | 2/11/2021 | To treat homozygous familial hypercholesterolemia |
| 5 | Ukoniq | umbralisib | 2/5/2021 | To treat marginal zone lymphoma and follicular lymphoma |
| 4 | Tepmetko | tepotinib | 2/3/2021 | To treat non-small cell lung cancer |
| 3 | Lupkynis | voclosporin | 1/22/2021 | To treat lupus nephritis |
| 2 | Cabenuva | cabotegravir and rilpivirine (co-packaged) | 1/21/2021 | To treat HIV |
| 1 | Verquvo | vericiguat | 1/19/2021 | To mitigate the risk of cardiovascular death and hospitalization for chronic heart failure |
Novel Drug Approvals for 2020
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 53 | Gemtesa | vibegron | 12/23/2020 | To treat overactive bladder |
| 52 | Ebanga | ansuvimab-zykl | 12/21/2020 | To treat ebola |
| 51 | Orgovyx | relugolix | 12/18/2020 | To treat advanced prostate cancer |
| 50 | Margenza | margetuximab (anti-HER2 mAb | 12/16/2020 | To treat HER2+ breast cancer |
| 49 | Klisyri | tirbanibulin | 12/14/2020 | To treat actinic Keratosis of the face or scalp |
| 48 | Orladeyo | berotralstat | 12/3/2020 | To treat patients with hereditary angioedema |
| 47 | Gallium 68 PSMA-11 | Gallium 68 PSMA-11 | 12/1/2020 | For detection and localization of prostate cancer |
| 46 | Danyelza | naxitamab-gqgk | 11/25/2020 | To treat high-risk refractory or relapsed neuroblastoma |
| 45 | Imcivree | setmelanotide | 11/25/2020 | To treat obesity and the control of hunger associated with pro-opiomelanocortin deficiency, a rare disorder that causes severe obesity that begins at an early age |
| 44 | Oxlumo | lumasiran | 11/23/2020 | To treat hyperoxaluria type 1 |
| 43 | Zokinvy | lonafarnib | 11/20/2020 | To treat rare conditions related to premature aging |
| 42 | Veklury | remdesivir | 10/22/2020 | To treat COVID-19 |
| 41 | Inmazeb | atoltivimab, maftivimab, and odesivimab-ebgn | 10/14/2020 | To treat ebola virus |
| 40 | Gavreto | pralsetinib | 9/4/2020 | To treat non-small lung cancer |
| 39 | Detectnet | copper Cu 64 dotatate injection | 9/3/2020 | To help detect certain types of neuroendocrine tumors |
| 38 | Sogroya | somapacitan-beco | 8/28/2020 | Growth hormone |
| 37 | Winlevi | clascoterone | 8/26/2020 | To treat acne |
| 36 | Enspryng | satralizumab-mwge | 8/14/2020 | To treat neuromyelitis optica spectrum disorder |
| 35 | Viltepso | viltolarsen | 8/12/2020 | To treat Duchenne muscular dystrophy |
| 34 | Olinvyk | oliceridine | 8/7/2020 | To manage acute pain in certain adults |
| 33 | Evrysdi | risdiplam | 8/7/2020 | To treat spinal muscular atrophy |
| 32 | Lampit | nifurtimox | 8/6/2020 | To treat Chagas disease in certain pediatric patients younger than age 18 |
| 31 | Blenrep | belantamab mafodotin-blmf | 8/5/2020 | To treat multiple myeloma |
| 30 | Monjuvi | tafasitamab-cxix | 7/31/2020 | To treat relapsed or refractory diffuse large B-cell lymphoma |
| 29 | Xeglyze | abametapir | 7/24/2020 | To treat head lice |
| 28 | Inqovi | decitabine and cedazuridine | 7/7/2020 | To treat adult patients with myelodysplastic syndromes |
| 27 | Rukobia | fostemsavir | 7/2/2020 | To treat HIV |
| 26 | Byfavo | remimazolam | 7/2/2020 | For sedation |
| 25 | Dojolvi | triheptanoin | 6/30/2020 | To treat molecularly long-chain fatty acid oxidation disorders |
| 24 | Zepzelca | lurbinectedin | 6/15/2020 | To treat metastatic small cell lung cancer |
| 23 | Uplizna | inebilizumab-cdon | 6/11/2020 | To treat neuromyelitis optica spectrum disorder |
| 22 | Tauvid | flortaucipir F18 | 5/28/2020 | Diagnostic agent for patients with Alzheimer’s disease |
| 21 | Artesunate | artesunate | 5/26/2020 | To treat severe malaria |
| 20 | Cerianna | fluoroestradiol F18 | 5/20/2020 | Diagnostic imaging agent for certain patients with breast cancer |
| 19 | Qinlock | ripretinib | 5/15/2020 | To treat advanced gastrointestinal-stromal tumors |
| 18 | Retevmo | selpercatinib | 5/8/2020 | To treat lung and thyroid cancers |
| 17 | Tabrecta | capmatinib | 5/6/2020 | To treat patients with non small cell lung cancer |
| 16 | Ongentys | opicapone | 4/24/2020 | To treat patients with Parkinson’s disease experiencing “off” episodes |
| 15 | Trodelvy | sacituzumab govitecan-hziy | 4/22/2020 | To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease |
| 14 | Pemazyre | pemigatinib | 4/17/2020 | To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts |
| 13 | Tukysa | tucatinib | 4/17/2020 | To treat advanced unresectable or metastatic HER2-positive breast cancer |
| 12 | Koselugo | selumetinib | 4/10/2020 | To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves |
| 11 | Zeposia | ozanimod | 3/25/2020 | To treat relapsing forms of multiple sclerosis |
| 10 | Isturisa | osilodrostat | 3/6/2020 | To treat adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease |
| 9 | Sarclisa | isatuximab | 3/2/2020 | To treat multiple myloma |
| 8 | Nurtec ODT | rimegepant | 2/27/2020 | To treat migraine |
| 7 | Barhemsys | amisulpride | 2/26/2020 | To help prevent nausea and vomiting after surgery |
| 6 | Vyepti | eptinezumab-jjmr | 2/21/2020 | For the preventive treatment of migraine in adults |
| 5 | Nexletol | bempedoic acid | 2/21/2020 | To treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C |
| 4 | Pizensy | lactitol | 2/12/2020 | To treat chronic idiopathic constipation (CIC) in adults |
| 3 | Tazverik | tazemetostat | 1/23/2020 | To treat epithelioid sarcoma |
| 2 | Tepezza | teprotumumab-trbw | 1/21/2020 | To treat Thyroid eye disease |
| 1 | Ayvakit | avapritinib | 1/9/2020 | To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) |
Novel Drug Approvals for 2019
| No. | Drug Name | Active Ingredient | Approval Date | FDA-approved use on approval date |
|---|---|---|---|---|
| 48 | Ubrelvy | ubrogepant | 12/23/2019 | to treat acute treatment of migraine with or without aura in adults |
| 47 | Enhertu | fam-trastuzumab deruxtecan-nxki | 12/20/2019 | To treat metastatic breast cancer |
| 46 | Dayvigo | lemborexant | 12/20/2019 | To treat insomnia |
| 45 | Caplyta | lumateperone tosylate | 12/20/2019 | To treat schizophrenia |
| 44 | TissueBlue | Brilliant Blue G Ophthalmic Solution | 12/20/2019 | Dye used in eye surgery |
| 43 | Padcev | enfortumab vedotin-ejfv | 12/18/2019 | To treat refractory bladder cancer |
| 42 | Vyondys 53 | golodirsen | 12/12/2019 | To treat certain patients with Duchenne muscular dystrophy |
| 41 | Oxbryta | voxelotor | 11/25/2019 | To treat sickle cell disease |
| 40 | Xcopri | cenobamate | 11/21/2019 | To treat partial onset seizures |
| 39 | Givlaari | givosiran | 11/20/2019 | To treat acute hepatic porphyria, a rare blood disorder |
| 38 | Adakveo | crizanlizumab-tmca | 11/15/2019 | To treat patients with painful complication of sickle cell disease |
| 37 | Fetroja | cefiderocol | 11/14/2019 | To treat patients with complicated urinary tract infections who have limited or no alternative treatment options |
| 36 | Brukinsa | zanubrutinib | 11/14/2019 | To treat certain patients with mantle cell lymphoma, a form of blood cancer |
| 35 | Reblozyl | luspatercept–aamt | 11/8/2019 | For the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions |
| 34 | ExEm Foam | air polymer-type A | 11/7/2019 | A diagnostic agent used to assess fallopian tube patency (openness) in women with known or suspected infertility |
| 33 | Trikafta | elexacaftor/ivacaftor/tezacaftor | 10/21/2019 | To treat patients 12 years of age and older with the most common gene mutation that causes cystic fibrosis |
| 32 | Reyvow | lasmiditan | 10/11/2019 | For the acute treatment of migraine with or without aura, in adults |
| 31 | fluorodopa F 18 | 10/10/2019 | A diagnostic agent for use in positron emission tomography (PET) to help diagnose adult patients with suspected Parkinsonian syndromes (PS) | |
| 30 | Scenesse | afamelanotide | 10/8/2019 | To increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria |
| 29 | Beovu | brolucizumab–dbll | 10/7/2019 | Treatment of wet age-related macular degeneration |
| 28 | Aklief | trifarotene | 10/4/2019 | For the topical treatment of acne vulgaris in patients 9 years of age and older |
| 27 | Ibsrela | tenapanor | 9/12/2019 | To treat irritable bowel syndrome with constipation in adults. |
| 26 | Nourianz | istradefylline | 8/27/2019 | To treat adult patients with Parkinson’s disease experiencing “off” episodes |
| 25 | Ga-68-DOTATOC | Ga-68-DOTATOC | 8/21/2019 | For use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) |
| 24 | Xenleta | lefamulin | 8/19/2019 | To treat adults with community-acquired bacterial pneumonia |
| 23 | Rinvoq | upadacitinib | 8/16/2019 | To treat adults with moderately to severely active rheumatoid arthritis |
| 22 | Inrebic | fedratinib | 8/16/2019 | To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis |
| 21 | Rozlytrek | entrectinib | 8/15/2019 | To treat adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive |
| 20 | Wakix | pitolisant | 8/14/2019 | To treat excessive daytime sleepiness (EDS) in adult patients with narcolepsy |
| 19 | pretomanid | 8/14/2019 | For treatment-resistant forms of tuberculosis that affects the lungs | |
| 18 | Turalio | pexidartinib | 8/2/2019 | To treat adult patients with symptomatic tenosynovial giant cell tumor |
| 17 | Nubeqa | darolutamide | 7/30/2019 | To treat adult patients with non-metastatic castration resistant prostate cancer |
| 16 | Accrufer | ferric maltol | 7/25/2019 | To treat iron deficiency anemia in adults |
| 15 | Recarbrio | imipenem, cilastatin and relebactam | 7/16/2019 | To treat complicated urinary tract and complicated intra-abdominal infections |
| 14 | Xpovio | selinexor | 7/3/2019 | To treat adult patients with relapsed or refractory multiple myeloma (RRMM) |
| 13 | Vyleesi | bremelanotide | 6/21/2018 | To treat hypoactive sexual desire disorder in premenopausal women. |
| 12 | Polivy | polatuzumab vedotin-piiq | 6/10/2019 | To treat adult patients with relapsed or refractory diffuse large B-cell lymphoma |
| 11 | Piqray | alpelisib | 5/24/2019 | To treat breast cancer |
| 10 | Vyndaqel | tafamidis meglumine | 5/3/2019 | To treat heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults |
| 9 | Skyrizi | risankizumab-rzaa | 4/23/2019 | To treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy |
| 8 | Balversa | erdafitinib | 4/12/2019 | To treat adult patients with locally advanced or metastatic bladder cancer |
| 7 | Evenity | romosozumab-aqqg | 4/9/2019 | To treat osteoporosis in postmenopausal women at high risk of fracture |
| 6 | Mayzent | siponimod | 3/26/2019 | To treat adults with relapsing forms of multiple sclerosis |
| 5 | Sunosi | solriamfetol | 3/20/2019 | To treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea |
| 4 | Zulresso | brexanolone | 3/19/2019 | To treat postpartum depression (PPD) in adult women |
| 3 | Egaten | triclabendazole | 2/13/2019 | To treat fascioliasis, a parasitic infestation caused by two species of flatworms or trematodes that mainly the affect the liver, sometimes referred to as “liver flukes” |
| 2 | Cablivi | caplacizumab-yhdp | 2/6/2019 | To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) |
| 1 | Jeuveau | prabotulinumtoxinA-xvfs | 2/1/2019 | For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients |