Granules India receives USFDA approval for Trospium Chloride Extended-Release Capsules

Granules India announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India for Trospium Chloride Extended-Release Capsules, 60 mg. It is bioequivalent to the reference listed drug product (RLD), Sanctura XR Capsules, 60 mg, of Allergan, Inc.

Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Trospium Chloride Extended-Release Capsules, 60 mg had U.S. sales of approximately $25 million MAT for the most recent twelve months ending in February 2020 according to IQVIA Health.

 

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