Strides subsidiary gets USFDA approval for Ethacrynic Acid pills

Our Bureau Bengaluru | Updated on October 20, 2020

Strides Pharma Science Limited (Strides) has announced that its step-down, wholly-owned subsidiary, Strides Pharma Global Pte Ltd, Singapore, has received approval for Ethacrynic Acid tablets USP, 25 mg from the US Food & Drug Administration (USFDA).

Ethacrynic acid is in a class of medications called diuretics (‘water pills’). It is used to treat edema (excess fluid held in body tissues) in adults and children caused by medical problems such as cancer, heart, kidney, or liver disease.

The company’s product is a generic version of Edecrin Tablets, 25 mg, of Bausch Health Americas, Inc.

According to IQVIA MAT August 2020 data, the US market for Ethacrynic Acid tablets USP, 25 mg is approximately $14 million. The product will be manufactured at the company’s flagship facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market.

The company has 126 cumulative ANDA filings with the USFDA, of which 92 ANDAs have been approved and 34 are pending approval.

Published on October 20, 2020

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