Lupin gets final USFDA nod to market anti-epilepsy drug

PTI Updated - March 12, 2018 at 12:36 PM.

Drug maker Lupin has received final approval from the US health regulator to market a generic version of UCB’s Keppra Oral Solution, an anti-epilepsy drug, in the American market.

The company’s subsidiary, Lupin Pharmaceuticals Inc, has received final approval for its Levetiracetam Oral Solution in the strength of 100mg/ml from US Food and Drug Administration (USFDA), Lupin said in a statement.

“Commercial shipment of the product shall commence shortly,” it added.

According to IMS Health sales data for the 12 months ended June 2011, Keppra Oral Solution 100 mg/mL had annual sales of nearly $63 million in the US market.

Last month, the company had received USFDA’s nod to sell a generic version of UCB’s Keppra XR tablets.

The company had received the approval to sell the tablets in the strengths of 500 mg and 750 mg. According to IMS Health sales data, Keppra XR tablets had annual sales of nearly $161 million in the US market.

Published on October 19, 2011 10:41