FDA Approves Generic Versions of HIV Drug

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Drugs Are Generic Versions of Retrovir; Oral Solution Available for Kids

ByMirandaHitti
WebMD Medical News

Reviewed ByBrunilda Nazario,MD
on Wednesday, September 21, 2005

Sept. 21, 2005 -- The FDA has approved the first generic versions of the AIDS drug Retrovir (zidovudine) for sale in the U.S. The approvals include a generic version of the drug for kids.

The drugs help keep HIV -- the virus which causes AIDS -- from reproducing.

Retrovir is made by GlaxoSmithKline, a WebMD sponsor. The newly approved generic versions are:

• Zidovudine tablets made by Ranbaxy Laboratories Limited of Guragon, India
• Zidovudine tablets and oral solution made by Aurobindo Pharma LTD of Hyderabad, India
• Zidovudine tablets made by Roxane Laboratories of Columbus, Ohio

Drugs for Kids, Adults

"For the first time, this antiretroviral drug will be available as a generic pediatric dosage form," states Health and Human Services Secretary Mike Leavitt, in an FDA news release.

"Zidovudine oral solution is a generic version of a child-friendly oral solution," FDA spokeswoman Rae Jones tells WebMD, in an email.

However, the newly approved generic drugs aren't just for kids, Jones notes.

"These approvals will now allow those infected by HIV more access to these lifesaving drugs within our country," states Leavitt. "Generic products help reduce costs to patients."

Previously, these generic drugs had been only tentatively approved and weren't available in the U.S. because patent or market exclusivity blocked their approval. Those patents have now expired, notes the FDA's news release.

SOURCES: News release, FDA. Rae Jones, spokeswoman, FDA.

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