Food and Drug Administration - January 8, 2009
Richard Klein & Kimberly Struble

On January 5, 2009, FDA granted approval for generic stavudine capsules, USP, 30 mg and 40 mg, manufactured by Matrix Laboratories, Limited, Hyberdad, India. The application was originally reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR) and granted tentative approval in April, 2007.

This full approval means that this generic formulation can be marketed in the US, as well as available for purchase by PEPFAR, because the patent protection has expired. Effective patent dates for approved drugs can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"

This is a generic formulation of Zerit brand capsules, 30 mg and 40 mg, made by Bristol Myers Squibb. 

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

090108
FD090101

SOURCE: Food and Drug Administration (FDA).

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