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On May 25, 2011, FDA granted tentative approval for a generic formulation of tenofovir disoproxil fumarate tablets, 300 mg under the expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR).
This formulation, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (≥12 years of age and ≥35 kg); and for the treatment of chronic hepatitis B in adults, is manufactured by Strides Arcolab Limited, of Bangalore, India.
"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.
This product is a generic version of Viread Tablets, 300 mg, manufactured by Gilead Sciences.
As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.
You can find a complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan on the FDA web site.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
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