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Mylan gets final FDA OK to market generic restless legs drug

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May 7, 2008

PITTSBURGH—Mylan Inc. said Wednesday it received final approval from the Food and Drug Administration to market its ropinirole hydrochloride tablets, the generic version of GlaxoSmithKline PLC's restless legs syndrome drug Requip.

Requip generated total U.S. sales of $518 million for the 12 months ended Dec. 31 for doses ranging between 0.25 milligrams and 5 mg, according to IMS Health.

The product will be shipped immediately, Mylan said.

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