FDA Gives Formal OKto Generic AIDS Drugs

Published Online: Thursday, December 1, 2005

The FDA gave formal approval to begin US marketing of several generic versions of GlaxoSmithKline's AIDS drug, zidovudine (Retrovir). Although some of these products have been available for purchase outside the United States as tentatively approved products under the President's Emergency Plan for AIDS Relief, they could not be sold in the United States because patent or market exclusivity blocked their approval, FDA officials said.

As a result of patent expirations, the FDA granted full US marketing authorization for the following products: (1) zidovudine tablets, manufactured by Ranbaxy Laboratories Ltd of Guragon, India; (2) zidovudine tablets and oral solution, manufactured by Aurobindo Pharma Ltd of Hyderabad, India; and (3) zidovudine tablets, manufactured by Roxane Laboratories of Columbus, Ohio.

"These approvals will now allow those infected with HIV more access to these life saving drugs within our country," said Michael Leavitt, secretary of Health and Human Services. "Generic products help reduce costs to patients, and, for the first time, this antiretroviral drug will be available as a generic pediatric dosage form."




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