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Approval of Generic Zidovudine

September 20, 2005

On September 19, 2005, FDA approved several generic formulations of Zidovudine for the U.S. market.

Previously, the products had been only tentatively approved and were not available in the United States because patent or market exclusivity blocked their approval for domestic marketing. With the expiration of those patents, the following products have received full marketing authorization for the United States:

  1. zidovudine tablets, 300 mg, manufactured by Ranbaxy Laboratories Limited of Guragon, India;
  2. zidovudine tablets, 300 mg and oral solution, 50 mg/5mL, manufactured by Aurobindo Pharma LTD. Hyderabad, India; and
  3. zidovudine tablets, 300 mg, manufactured by Roxane Laboratories of Columbus, Ohio, U.S.A.

These are the first generic versions of the already-approved Retrovir brand manufactured by GlaxoSmithKline to be approved for marketing in the U.S. FDA previously determined, as part of a tentative approval action, that these products meet all U.S. manufacturing quality and clinical safety and efficacy standards.

Zidovudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This antiretroviral drug is intended to be used with other antiretroviral agents for the treatment of HIV infection.

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