Strides gets FDA nod for generic Urso

Strides Pharma Global has garnered the Food and Drug Administration’s stamp of approval for ursodiol tablets in dosage strengths of 250 mg and 500 mg.

The product is a generic of Allergan’s Urso 250 tablets 250 mg and Urso Forte tablets 500 mg. It is indicated to treat primary biliary cirrhosis.

Ursodiol tablets, 250 mg and 500 mg, had a market value of approximately $35 million, according to IQVIA June 2020 data.

The product will be manufactured at the company’s flagship facility at Bengaluru in India and will be marketed by Strides Pharma in the U.S. market.