Taro receives FDA Approval for Keppra® (Levetiracetam tablets)

Taro Pharmaceutical Industries Ltd. has received approval from the USFDA for its ANDA for Levetiracetam Tablets, 250 mg, 500 mg, 750 mg and 1000 mg. Taro's levetiracetam tablets is a prescription product used in the treatment of epilepsy, and is bioequivalent to UCB's Keppra® Tablets. According to industry sources, levetiracetam tablets had U.S. sales of over $700 million in 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.

Cypress receives FDA approval of Levetiracetam oral solution

Cypress has been granted final approval by USFDA for it's ANDA for Levetiracetam Oral Solution, 100 mg/mL. Levetiracetam Oral Solution, 100 mg/mL is the AB-rated bioequivalent generic to UCB Pharma's Keppra® Oral Solution, 100 mg/mL.