Strides Pharma obtains FDA clearance for generic Actigal

Patients with Primary Biliary Cirrhosis will soon have a new generic treatment available.

Strides Pharma’s subsidiary, Strides Pharma Global, Singapore, has received The Food and Drug Administration’s nod for Ursodiol capsules in a dosage strength of 300 mg.

The medication is the generic of Allergan’s Actigal capsules.

Ursodiol capsules had a market value of approximately $45 million, according to IQVIA November data.

The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma in the United States.