Food and Drug Administration - December 22, 2005
Richard Klein

The Food and Drug Administration (FDA) granted, on December 21, 2005, tentative approval to generic stavudine for Oral Solution, 1 mg/mL manufactured by Aurobindo Pharma LTD., of Hyderabad, India. This product is the first generic version of the approved product, Zerit for oral solution, manufactured by Bristol-Myers Squibb. This child-friendly product is indicated for use in pediatric patients with HIV from birth through adolescence.

Stavudine (d4T) is active against the human immunodeficiency virus (HIV) that causes AIDS. It is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which helps keep the AIDS virus from reproducing, and is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

FDA tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the U.S., it meets all of FDA's manufacturing quality and clinical safety and efficacy standards required for marketing in the U.S. As with all generic application assessments, 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 assess the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

Tentative approval by FDA means that this product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief.

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration

051222
FD051205

SOURCE: Food and Drug Administration (FDA).

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