Bengaluru-based Strides Pharma gets US FDA nod for generic drug

Strides Pharma Science on Monday said it has received approval from the US health regulator to market generic Ursodiol capsules, used in the treatment of Primary Biliary Cirrhosis (PBC), in the American market.

The company's step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, Singapore, has received approval for Ursodiol capsules in 300 mg strength from the United States Food & Drug Administration (US FDA), the drugmaker said in a statement.

The company's product is bioequivalent and therapeutically equivalent to Allergan Sales' Actigall capsules, it added.

According to IQVIA MAT November 2020 data, the US market for Ursodiol Capsules USP 300 mg is around $45 million.

"The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market," the company said.

Bengaluru-based Strides Pharma has 127 cumulative abbreviated new drug applications (ANDA) filings with US FDA of which 96 have been approved and 31 are pending approval.