Strides gets USFDA approval for Icosapent Ethyl Capsules

Strides Pharma Science on September 23, 2023 announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Icosapent Ethyl Capsules 0.5 gram and 1 gram, from the United States Food & Drug Administration (USFDA). The product complements Strides’ range of approved soft gelatin capsules.

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vascepa of Amarin. The Icosapent Ethyl Capsules has a market size of $1.3 billion per IQVIA. The product will be manufactured at the company’s facility in Bengaluru.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.