AEGiS-UPI: FDA tentatively OKs generic AIDS drug United Press InternationalImportant note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
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FDA tentatively OKs generic AIDS drug

United Press International - November 4, 2005


WASHINGTON - The Food and Drug Administration has given tentative approval to the first generic version of GlaxoSmithKline's AIDS drug Epivir.

The agency said it has approved Lamivudine oral solution 10 mg/ml, manufactured by Aurobindo Pharma Ltd. in Hyderabad, India.

The generic drug -- based on GSK's Epivir oral solution -- is indicated for use in children ages 3 months to 16 years. The anti-retroviral treatment, intended for use in combination with other drugs in its class, helps prevent HIV from reproducing.

The drug is now available for government purchase through President George W. Bush's Emergency Plan for AIDS Relief, announced in 2003, the FDA said in a statement. Wider domestic distribution is prohibited because GSK's patent rights preclude Lamivudine's sale in the United States.


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