Granules India gets USFDA nod for Trospium Chloride ER Capsules
Hyderabad: Granules India Limited has 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 Limited 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.
"We are pleased to announce the approval of this niche, limited competition product, which is a nice addition to our growing product portfolio in the US market," said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc., commenting on the approval.
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