Food and Drug Administration - December 29, 2008
Richard Klein & Kimberly Struble

On December 29, 2008 FDA granted approval for three generic fomulations of stavudine. Stavudine is a Nucleoside Reverse Transcriptase Inhibitors (NRTI), which helps keep HIV, the virus that causes AIDS, from reproducing. It is intended to be used in combination with other anti-retroviral agents for the treatment of HIV-1 infection.

The approved generic formulations are stavudine capsules (15 mg, 20 mg, 30 mg and 40 mg), and Stavudine for Oral Solution (1 mg/mL), both manufactured by Aurobindo Pharma; and stavudine capsules (15 mg, 20 mg, 30 mg and 40 mg) manufactured by Hetero Drugs Limited, both of Hyberdad, India.

FDA has determined that Aurobindo's stavudine for oral solution and stavudine capsules are bioequivalent and, therefore, therapeutically equivalent to Zerit oral solution 1mg/mL and 15 mg, 20 mg, 30 mg, and 40 mg capsules, respectively, made by Bristol-Myers Squibb.

Similarly, Hetero's stavudine capsules were determined to be bioequivalent, and thus therapeutically equivalent to Zerit Capsules, 15 mg, 20 mg, 30 mg, and 40 mg.

The patent and pediatric exclusivity protections associated with the originator product have expired, so these generic formulations are approved for marketing in the United States.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration 

081229
FD081208

SOURCE: Food and Drug Administration (FDA).

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