Strides Pharma Science arm gets USFDA nod for Ethacrynic Acid tablets
Drug firm Strides Pharma Science on Tuesday said its step down subsidiary has received approval from the US health regulator for Ethacrynic Acid tablets, used to treat fluid retention (edema).
The approved product is a generic version of Edecrin tablets, 25 mg, of Bausch Health Americas.
Strides Pharma Global, Singapore, has received approval for Ethacrynic Acid tablets USP in the strengths of 25 mg from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.
Quoting IQVIA moving annual total (MAT) August 2020 data, Strides Pharma Science said the US market for Ethacrynic Acid tablets USP, 25 mg, is approximately USD 14 million.
The product will be manufactured at the company's flagship facility at Bengaluru and will be marketed by Strides Pharma in the US market, the company added.
The company has 126 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 92 ANDAs have been approved and 34 are pending for approval.
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.
Shares of Strides Pharma Science were trading 0.95 per cent higher at Rs 753.60 apiece on BSE.