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Strides Pharma Science Limited (Strides) announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval from the United States Food & Drug Administration (FDA) for icosapent ethyl capsules 0.5 gram and 1 gram.
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 US$ 1.3 billion as per IQVIA. The product will be manufactured at the company’s facility in Bengaluru.
The Bengaluru-based company has 260 cumulative ANDA filings including the recently acquired portfolio from Endo at Chestnut Ridge with US FDA, of which 230+ ANDAs have been approved. It has set a target to launch ~ 60 new products over three years in the US.
Icosapent ethyl capsule is a prescription medication used in conjunction with other medicines like statins to reduce the risk of heart attack, stroke and heart issues in those afflicted with cardiovascular disease. The product complements Strides’ range of approved soft gelatin capsules.
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