Strides Pharma Science gets USFDA nod for generic capsule to control triglyceride level

The approval granted by the US Food & Drug Administration (USFDA) to Strides Pharma Global Pte. Limited, Singapore, is for Icosapent Ethyl Capsules 0.5 gram and 1 gram, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug Vascepa of Amarin.

Updated On Oct 3, 2023 at 06:01 PM IST

New Delhi: Strides Pharma Science Ltd on Tuesday said its wholly-owned arm has received approval from the US health regulator for its generic version of Icosapent Ethyl capsules used to control triglyceride levels in the blood.

The approval granted by the US Food & Drug Administration (USFDA) to Strides Pharma Global Pte. Limited, Singapore, is for Icosapent Ethyl Capsules 0.5 gram and 1 gram, Strides Pharma Science said in a regulatory filing.

The product is bioequivalent and therapeutically equivalent to the reference listed drug Vascepa of Amarin.

It will be manufactured at the company's facility in Bengaluru, it added.

The Icosapent Ethyl capsules have a market size of around USD 1.3 billion, Strides said, citing IQVIA.