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Strides Pharma Science arm gets USFDA nod for anti-epileptic drug

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The approved product is a generic version of Zarontin Capsules, 250 mg, of Pfizer 

Strides Pharma Science has received approval from the US health regulator for Ethosuximide Softgel capsules, an anti-epileptic medication. The approved product is a generic version of Zarontin Capsules, 250 mg, of Pfizer.

“Strides Pharma Global, Singapore, has received approval for Ethosuximide Softgel Capsules USP, 250 mg, from the United States Food and Drug Administration (USFDA),” Strides Pharma Science said in a BSE filing. The product was approved in the first review cycle by the USFDA in less than 10 months of filing. Citing IQVIA data, the company said the US market for Ethosuximide Softgel Capsules USP, 250 mg, is approximately $10 million.

Strides said Ethosuximide Softgel capsules are part of its niche and small volume product portfolio with limited competition in the US market. “As part of its portfolio maximisation strategy, Strides will also commercialise the product in other geographies, leveraging its vast footprint in other regulated markets,” the company added.

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