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Lupin gets USFDA nod to market anti-epilepsy drug

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Press Trust of India New Delhi

Drug maker Lupin today said it 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 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 twelve 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 Sales Health sales data Keppra XR tablets had annual sales of nearly $161 million in the US market.

Shares of Lupin were trading at Rs 472.60 on the BSE in the late afternoon trade, up 1.07% from its previous close.

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First Published: Oct 19 2011 | 3:36 PM IST

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