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U.S. Department of Health and Human Services

For Consumers

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Tentative approval of generic stavudine

FDA granted tentative approval on April 23, 2007 for a generic formulation for stavudine capsules, 30 mg and 40 mg, manufactured by Matrix Laboratories Limited of Hyderabad, India, under expedited review provisions developed 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, even though it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible 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 is a generic formulation of the already approved Zerit brand capsules, 30 mg and 40 mg, made by Bristol Myers Squibb, which is protected by existing patent and pediatric exclusivity rights.  Effective patent dates are listed in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"

Stavudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI) indicated for used in combination with other antiretroviral agents in the treatment of HIV infection.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration