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For Consumers

Tentative approval lamivudine/zidovudine + nevirapine

The Food and Drug Administration granted tentative approval on March 2, 2007 for a fixed dose tablet containing lamivudine/zidovudine(150 mg/300 mg) tablets, co-packaged with Nevirapine(200 mg tablets for the treatment of HIV-1 infection, manufactured by Strides Arcolab Ltd, Bangalore, India.

The lamivudine/zidovudine combination is a generic formulation of the FDA approved combination product, Combivir, manufactured by GlaxoSmithKline, which combines the two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in a single tablet. Nevirapine, which is a Nucleoside Reverse Transcriptase Inhibitor (NNRTI), is a generic formulation of the approved product, Viramune, manufactured by Boehringer Ingelheim.

The application was reviewed under expedited review provisions for 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, though it may not be marketed in the U.S. because of existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase under the PEPFAR program.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/06/2014
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