FDAnews
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FDA APPROVES GENERIC HIV/AIDS DRUG

March 31, 2006

The FDA has issued the first generic approval for the capsule dosage form of zidovudine to treat HIV/AIDS to be marketed in the U.S. The tablet and oral solution dosage forms of zidovudine were previously approved for sale in the U.S. when the patent on those dosage forms expired in September 2005.

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