FDA OK's Generic Versions of AIDS Drugs

Sep. 25, 2005

Associated Press

The FDA has approved the first generic versions of the AIDS medication AZT, a move that could reduce the expense for people in the United States being treated for the disease.

AZT, an anti-retroviral drug that is also known as Zidovudine, helps prevent the AIDS virus 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 those patents have expired, versions of drug manufactured by Roxane Laboratories of Columbus, Ohio; Ranbaxy Laboratories of Guragon, India, and Aurobindo Pharma of Hyderabad, India, can go on the market.

The United States is home to nine of the world's largest pharmaceutical companies and U.S. corporations supply 60 to 70 percent of the world's new medicines. The report sheds light on how drug companies operate here in the local market and internationally where millions depend on U.S. drugs and companies.

The original, sold under the name Retrovir, is manufactured by GlaxoSmithKline. The Food and Drug Administration first approved Retrovir in 1987. A 300-milligram tablet can cost $7.

"These approvals will now allow those infected with HIV more access to these life-saving drugs within our country," said Mike Leavitt, secretary of the Department of Health and Human Services, in a statement.

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