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U.S. Department of Health and Human Services

For Consumers

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Tentative approval of lamivudine/nevirapine/zidovudine 150 /200 /300 mg fixed-dose combination

On November 18, 2011, the Food and Drug Administration (FDA) granted tentative approval for a triple-drug fixed-dose combination tablet containing lamivudine, nevirapine, and zidovudine, 150 mg/200 mg/300 mg, indicated for use in combination with other antiretrovirals for the treatment of HIV-1 infection. The tablet is manufactured by Hetero Labs Limited of Hyderabad, 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 President's Emergency Plan for AIDS Relief (PEPFAR) program.

These products were reviewed under expedited review provisions for PEPFAR under the FDA guidance titled Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously approved Antiretrovirals for the Treatment of HIV, to facilitate submission of such applications to FDA.

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 Drug Products
Food and Drug Administration