Strides Pharma Science has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Singapore, has received approval for Ursodiol tablets USP, 250 mg and 500 mg from the United States Food & Drug Administration (FDA).
The product is a generic version of Urso, 250 mg and Urso Forte tablets 500 mg, of Allergan Sales, LLC.
According to IQVIA MAT June 2020 data, the US market for Ursodiol tablets USP, 250 mg and 500 mg is approximately US$ 35 million The product will be manufactured at the company’s flagship facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
The company has 126 cumulative ANDA filings with US FDA of which 88 ANDAs have been approved and 38 are pending approval.
Ursodiol tablets are indicated for the treatment of patients with Primary Biliary Cirrhosis (PBC).