Strides get USFDA nod for Ursodiol capsules

Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Ursodiol Capsules USP, 300 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Actigall Capsules, 300 mg, of Allergan Sales.

Ursodiol capsules are indicated for the treatment of patients with Primary Biliary Cirrhosis (PBC).

According to IQVIA MAT November 2020 data, the US market for Ursodiol Capsules USP, 300 mg is approximately $ 45 million. The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma in the US market.

The company has 127 cumulative ANDA filings with USFDA of which 96 ANDAs have been approved and 31 are pending approval.