Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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Food and Drug Administration - June 27, 2008
Richard Klein & Kimberly Struble
On June 26, 2008, FDA granted approval for a generic Zidovudine Oral Solution USP, 50 mg/5 mL formulation manufactured by Cipla Limited of of Mumbai, India. The is a full approval, meaning that this generic zidovudine formulation can be marketed in the United States. The application was reviewed under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR).
Other oral solution and tablet dosage forms of generic zidovudine were approved for sale in the United States following expiration of patents for GlaxoSmithKline's Retrovir brand product.
A list of FDA approved generic antiretroviral drugs for the treatment of HIV is available on the web at http://www.fda.gov/oashi/aids/viralsgeneric.html
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
080627
FD080607
SOURCE: Food and Drug Administration (FDA).
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