Strides Pharma gets USFDA nod for generic version of Edecrin Tablets
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.
Bengaluru: Strides Pharma Science Limited today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ethacrynic Acid Tablets USP, 25 mg from the United States Food & Drug Administration (USFDA).
The product is a generic version of Edecrin Tablets, 25 mg, of Bausch Health Americas, Inc.
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 has 126 cumulative ANDA filings with USFDA of which 92 ANDAs have been approved and 34 are pending approval.