Strides Pharma secures USFDA okay for Primary Biliary Cirrhosis drug Ursodiol
Ursodiol tablets are indicated for the treatment of patients with Primary Biliary Cirrhosis(PBC).;
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Bengaluru: Drug major, Strides Pharma Science Limited, today announced that the company's step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, 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, LLC.
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