HIV/AIDS Update - Tentative approval: lamivudine and tenofovir disoproxil fumarate FDC tablets with nevirapine

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Title: HIV/AIDS Update - Tentative approval: lamivudine and tenofovir disoproxil fumarate FDC tablets with nevirapine

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On 3/14/2014 FDA granted tentative approval for lamivudine and tenofovir disoproxil fumarate Fixed-Dose Combination tablets, 300 mg/300 mg, co-packaged with nevirapine tablets, 200 mg, indicated alone or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and adolescents 16 years of age and older and weighing at least 35 kg.

The product is manufactured by Hetero Labs Limited of Hyderabad, India.

The application was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR).

"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.

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.

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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