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For Consumers

Tentative approval of generic stavudine capsules

On August 28, 2006, FDA granted tentative approval for stavudine capsules, 30 mg and 40 mg, manufactured by Strides Acrolab Ltd., Bangalore, India, under the expedited review provisions created for the President's Emergency Plan for AIDS Relief (PEPFAR).

FDA's tentative approval means that although the product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., existing patents and/or exclusivity currently prevent marketing of this product in the United States.  Tentative approval, however, qualifies the product for consideration for purchase under the PEPFAR program.

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.

This product is a generic version of Zerit Capsules, 30 mg and 40 mg, a nucleoside reverse transcriptase inhibitor (NRTI) used in combination with other antiretroviral agents for the treatment of HIV-1 infection, manufactured by Bristol-Myers Squibb.

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: 08/05/2014
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