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September 22, 2005

First generic versions of AZT approved

The Food and Drug Administration has approved the first generic versions of the anti-HIV medication AZT, a move that could reduce the expense for people in the United States being treated for the disease. AZT, an antiretroviral drug that is also known as zidovudine or by its brand name Retrovir, helps prevent HIV from reproducing in the body. It is often used in combination with other medications to treat an HIV infection.

Generic versions of the drug have previously been unavailable in the United States because patent or market exclusivity restrictions prevented them from being marketed. Now that the patent expired on Saturday, September 17, versions of the drug manufactured by Roxane Laboratories of Columbus, Ohio; Ranbaxy Laboratories Ltd. of New Delhi, India; and Aurobindo Pharma Ltd. of Hyderabad, India, have been approved by the FDA to go on the U.S. market.

“These approvals will now allow those infected with HIV more access to these lifesaving drugs within our country,” said Mike Leavitt, secretary of the Department of Health and Human Services, in a statement. (AP)

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