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FDA approves generic versions of HIV drug |
March 03, 2008
Drugs are generic versions of retrovir; oral solution Available for kids
The FDA has approved the first generic versions of the AIDS drug Retrovir (zidovudine) for sale. 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, 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," Zidovudine oral solution is a generic version of a child-friendly oral solution”.
However, the newly approved generic drugs aren't just for kids.
These approvals will now allow those infected by HIV more access to these lifesaving drugs within country, 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.
Source: medindia.com
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