Aurobindo Pharma Ltd, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received final approvals from the US Food and Drug Administration (US FDA) for Levetiracetam tablets in 250 mg, 500mg, 750 mg and 1000mg strengths and Levetiracetam oral solution in 100mg/ml form.
With the new approval, the company now has a total of 89 abbreviated new drug application (ANDA) approvals – 65 final and 24 tentative.
Levetiracetam tablets 250 mg, 500mg, 750 mg and 1000mg and Levetiracetam oral solution 100mg/ml are the generic equivalents of UCB Inc’s Keppra tablets 250mg, 500mg, 750 mg and 1000mg and Koppra oral solution 100mg/ml respectively.
“Both the products had a market size of close to $1.15 billion for the 12 months ending June 2008,” the company stated in a press release on Friday.
The new drugs fall under the central nervous system (CNS) segment and are indicated as adjunctive therapy in the treatment of myclonic seizures in adults and adolescents from 12 years of age with juvenile muclonic epilepsy.
