Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global, 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. It is used to treat oedema (excess fluid held in body tissues) in adults and children caused by medical problems such as cancer, heart, kidney, or liver disease.
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 in the US market.
The company has 126 cumulative ANDA filings with USFDA of which 92 ANDAs have been approved and 34 are pending approval. Ethacrynic acid is in a class of medications called diuretics (water pills).