Wednesday, December 16, 2009

USFDA grants approval to Mylan's generic version of Keppra 1000mg

Mylan has received final approval from the USFDA for its ANDA for Levetiracetam Tablets, 1000 mg. Levetiracetam Tablets are the generic version of UCB Pharma's antiepileptic Keppra®. This additional strength of Levetiracetam Tablets complements Mylan's already approved and marketed strengths of 250 mg, 500 mg and 750 mg. Levetiracetam Tablets, 1000 mg had U.S. sales of approximately $136 million for the 12 months ending Sept. 30 and is shipping immediately.

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