AEGiS-FDA: Tentative approval of generic zidovudine

Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.

Tentative approval of generic zidovudine

Food and Drug Administration - August 30, 2005
Richard Klein

The Food and Drug Administration, on August 25, 2005, granted tentative approval to zidovudine 300 mg tablets manufactured by Aurobindo Pharma LTD., Hyderabad, India. Tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States, it meets the quality, safety and efficacy standards for U.S. marketing.

The tablets are a generic version of the already-approved Retrovir brand of the product manufactured by GlaxoSmithKline.

The tentative approval by FDA makes Aurobindo Pharma's generic zidovudine eligible for purchase and use outside the United States under the President's Emergency Plan for AIDS Relief (PEPFAR).

On July 13, 2005, FDA granted tentative approval to a generic combination drug product manufactured by Aurobindo consisting of lamivudine and zidovudine. Another generic version of zidovudine tablets, manufactured by Ranbaxy Laboratories Limited of Guragon, India received tentative approval on July 13, 2005.

Zidovudine is a nucleoside reverse transcriptase inhibitor (NRTIs), intended to be used with other antiretroviral agents for the treatment of HIV-1 infection.

Richard Klein, Office of Special Health Issues, Food and Drug Administration

Kimberly Struble, Division of Antiviral Drug Products, Food and Drug Administration

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SOURCE: Food and Drug Administration (FDA).

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