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On September 12, 2014, FDA granted tentative approval to emtricitabine and tenofovir disoproxil fumarate fixed dose combination tablets, 200 mg/300 mg, co-packaged with nevirapine tablets, 200 mg.
A product of Mylan Laboratories, the combination product is indicated alone or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 38 kg.
"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for purchase outside the United States under the PEPFAR program.
The application was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR).
A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA web site.
For information about patent terms, consult the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
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