Strides gets USFDA approval for Ethosuximide Softgel capsules

The product was approved by the USFDA in the first review cycle in less than 10 months of its filing under the GDUFA II regime.

Feb 20, 2019 06:02 IST India Infoline News Service

Strides
Strides Pharma Science on Wednesday announced that its step‐down wholly-owned subsidiary Strides Pharma Global Pte Ltd, Singapore, has received approval for Ethosuximide Softgel Capsules USP, 250 mg, from the United States Food & Drug Administration (USFDA).

The product is a  generic version of Pfizer's Zarontin Capsules, 250 mg.

The product was approved in the first review cycle in less than 10 months of its filing under the GDUFA II regime. Strides specializes in the softgel domain and is a global leader in the Rx space.

Strides now has a large portfolio of softgel products, comprising 10 approved products for the US markets along with a strong product pipeline. Ethosuximide Softgel Capsules is part of Strides' niche and small volume product portfolio with limited competition in the US market. 

According to IQVIA MAT data, the US market for Ethosuximide Softgel Capsules USP, 250 mg, is approximately $10mn. As part of its portfolio maximization strategy, Strides will also commercialize the product in other geographies leveraging its vast footprint in other regulated markets.

The product will be manufactured at its flagship facility in Bengaluru and will be marketed by Strides Pharma Inc. in the US. 

The company has 86 cumulative ANDA filings with the USFDA, of which, 57 ANDAs have been approved, including 13 approvals received in FY19.

Strides Pharma Science Ltd share price is currently at Rs404.85, up Rs1.95, or 0.48%, from its previous close of Rs402.90 on the BSE. The scrip opened at Rs406 and has touched a high and low of Rs411.85 and Rs404.20, respectively. 

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