Generic zidovudine capsules approved

FDA granted approval, on May 23, 2007, to a generic formulation of zidovudine capsules, 100 mg, manufactured by Cipla Limited, of Mumbai, India.  The approval means that these generic zidovudine capsules can be marketed in the United States. 

Tablet and oral solution dosage forms of generic zidovudine were previously approved for sale in the United States as the patents on those dosage forms expired in September 2005.  An earlier generic version of the capsule formulation was approved for marketing in the United States in 2006, following the expiration of GlaxoSmithKline's patent on its Retrovir brand capsule.

A list of FDA approved generic antiretroviral drugs for the treatment of HIV is available on the FDA web site.

Zidovudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing.  This anti-retroviral drug is intended to be used with other anti-retroviral agents for the treatment of HIV-1 infection.

The approval of generic zidovudine means that there are no existing patents and/or exclusivity preventing the approval of generic versions of this product to prevent marketing in the United States. 

As with all FDA-approved generics, this product must meet all of FDA's manufacturing quality, and clinical safety and effectiveness standards for U.S. marketing. 

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration