Strides Pharma Science arm gets USFDA nod for ethacrynic acid tablets
Pharmaceutical company Strides Pharma Science said on Tuesday that its resigning subsidiary had received approval from the U.S. health regulator for ethacrynic acid tablets, used to treat fluid retention (edema).
The approved product is a generic version of Edecrin 25 mg tablets from Bausch Health Americas.
Strides Pharma Global, Singapore, has received approval for Ethacrynic Acid Tablets USP in strengths of 25 mg from the United States Food and Drug Administration (USFDA), Strides Pharma Science has reported in a regulatory filing.
Citing the August 2020 IQVIA Annual Moving Total (MAT) data, Strides Pharma Science said the US market for Ethacrynic Acid Tablets USP, 25 mg, is approximately $ 14 million.
The product will be manufactured at the company’s flagship plant in 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 the USFDA, of which 92 ANDAs have been approved and 34 are pending approval.
Ethacrynic acid belongs to a class of medicines called diuretics (water pills). It is used to treat edema (excess fluid in body tissue) in adults and children caused by medical problems such as cancer, heart disease, kidney disease or liver disease.
Shares of Strides Pharma Science were trading 0.95% higher at Rs 753.60 each on BSE.
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