FDA approves generic version of Epivir

10/24/2008

WASHINGTON The Food and Drug Administration has granted tentative approval to Indian drug maker Macleods Pharmaceuticals’ generic version of GlaxoSmithKline’s HIV drug Epivir (lamivudine), FDA records show.

The drug would be available as 150 mg and 300 mg tablets, but cannot be marketed in the United States because of patent protection.

GSK’s patent for lamivudine will expire in 2010. Epivir had sales of $246.85 million in 2007, according to GSK financial records.

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