Tenofovir: Difference between revisions
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Revision as of 01:53, 30 January 2013
See also Tenofovir (patient information).
History
Viread brand of tenofovir was approved for Gilead Sciences by the Food and Drug Administration in the United States with a New Drug Application (NDA) in 2001.[1]
A generic version with a AB Therapeutic Equivalence Code was approved for Cipla Limited with a Abbreviated New Drug Application (ANDA) in 2009.[2] The generic ANDA was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR) with the agreement that the drug would not be marketed in the United States until the Viread patent protection expires in 2017.
references
- ↑ Anonymous. Drugs@FDA for FDA Application No. 021356. U S Food and Drug Administration
- ↑ Anonymous. Drugs@FDA for FDA Application No. 078800. U S Food and Drug Administration