Granules India Limited announced that the US Food and 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 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.
Trospium Chloride Extended-Release Capsules, 60 mg had US sales of approximately $25 million MAT for the most recent twelve months ending in February 2020, according to IQVIA Health. Granules has a total of 26 ANDA approvals from US FDA (24 Final approvals and 2 tentative approvals).