AEGiS-FDA: Tentative approval: generic stavudine 15 & 20 mg capsules

Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.

Tentative approval: generic stavudine 15 & 20 mg capsules

Food and Drug Administration - June 28, 2006
Richard Klein

The Food and Drug Administration, on June 27, 2006, granted tentative approval for stavudine 15 and 20 mg capsules manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India. Tentative approval was granted to the same manufacturer for generic stavudine, 30 and 40 mg capsules on July 1, 2005, and for Oral Solution, 1 mg/mL on December 21, 2006.

This is a generic version of the already-approved Zerit brand of the product manufactured by Bristol Myers-Squibb.

The application was reviewed under the expedited review provisions 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, though it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) program.

Stavudine is a member of the class of drugs called Nucleoside Reverse Transcripts Inhibitors (NRTIs) which helps keep the AIDS virus from reproducing. Stavudine is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Richard Klein, Office of Special Health Issues

Food and Drug Administration
060628
FD060604

SOURCE: Food and Drug Administration (FDA).

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