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Last Updated : Oct 01, 2019 05:04 PM IST | Source: PTI

Lupin gets USFDA nod to market its anti-epileptic capsules in US

The capsules are indicated for prevention and treatment of seizures occurring during or following neurosurgery and for treatment of tonic-clonic and psychomotor seizures.

Drug firm Lupin on October 1 said it has received nod from US health regulator to market its anti-epileptic extended Phenytoin Sodium capsules in the American market.

The company has received approval from the United States Food and Drug Administration (USFDA) for its generic extended Phenytoin Sodium capsules USP in 100 mg strength, Lupin said in a statement.

The company's product is a generic version of Pfizer Inc's division Parke-Davis' Dilantin capsules in the same strength, it added.

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As per IQVIA MAT June 2019 data, extended Phenytoin Sodium capsules USP, 100 mg had annual sales of approximately USD 105 million (about Rs 735 crore) in the US, Lupin said.

The capsules are indicated for prevention and treatment of seizures occurring during or following neurosurgery and for treatment of tonic-clonic and psychomotor seizures, it added.

Shares of Lupin closed at Rs 703.20 per scrip on the BSE, down 1.70 percent from its previous close.

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First Published on Oct 1, 2019 04:55 pm
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