Mylan Inc. has announced it has received final FDA approval for its Abbreviated New Drug Application (ANDA) for 1,000 mg levetiracetam tablets.
Levetiracetam tablets are the generic version of UCB Pharma's antiepileptic medication Keppra. This dosage of levetiracetam tablets had sales in the U.S. of approximately $136 million for the 12 months ending September 30.
This additional strength of levetiracetam tablets joins Mylan's already approved and marketed strengths of 250 mg, 500 mg and 750 mg. The newly approved dosage is shipping immediately.
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Michael Laffin
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