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For Consumers

Tentative approval of stavudine/lamivudine/nevirapine fixed dose combination tablets

On July 16, 2009, the Food and Drug Administration (FDA) granted tentative approvalfor stavudine, lamivudine, and nevirapine fixed dose combination tablets, 40mg/150mg/200mg & 30mg/150mg/200mg manufactured by Emcure Pharmaceuticals Limited of Pune, India.The combination product is indicated for use alone as a complete regimen, or in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Combination products like this one can decrease pill burden and may result in improved dosing compliance for HIV infected individuals.

FDA's tentative approval of this product means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product has been shown to meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and thus qualifies for consideration for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR).

As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

The application was reviewed under expedited review provisions for PEPFAR,  A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA website.

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: 08/20/2014
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