Strides Pharma trades 2% up after USFDA nod for drug to reduce heart issues

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.

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Shares of Strides Pharma Science gained 2 percent in the early trade on September 25 after the company’s subsidiary received approval for its cardiac drug from the US Food and Drug Administration (USFDA).

At 9:19am, Strides Pharma Science was quoting Rs 509.95, up Rs 11.30, or 2.27 percent, on the BSE.

Strides Pharma Global Pte Limited, Singapore, a step‐down wholly owned subsidiary of the company, has received approval for Icosapent Ethyl Capsules 0.5 gram and 1 gram, from the USFDA.

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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The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vascepa of Amarin and 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.

Earlier in this month, the subsidiary had received tentative approval for its New Drug Application (NDA) 505b2 of Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumurate 50mg/ 300mg/ 300mg tablets from the USFDA.

Also, received tentative approval for Dolutegravir 50mg tablets from the US Food and Drug Administration (USFDA). Both the products will be manufactured at the company’s facility in Bengaluru.