Granules India gets US FDA nod for overactive bladder treatment capsule

Drug firm Granules India said it has received approval from the US health regulator for generic Trospium Chloride extended-release capsules used for the treatment of overactive bladder.

“The US Food and Drug Administration (US FDA) has approved the abbreviated new drug application filed by Granules Pharmaceuticals, Inc, a wholly owned foreign subsidiary of Granules India, for Trospium Chloride extended-release capsules, 60 mg,” the company said.

The product is generic version of Allergan’s Sanctura XR capsules in the same strength, it added.

“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,” Granules Pharmaceuticals Inc ED Priyanka Chigurupati said.

According to IQVIA Health, Trospium Chloride extended-release capsules, 60 mg had US sales of approximately USD 25 million MAT for the most recent twelve months ending in February 2020, Granules India said.

The product is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency, it added.

The company now has a total of 26 abbreviated new drug application (ANDA) approvals from USFDA (24 final approvals and 2 tentative approvals), Granules India said.

Shares of Granules India Ltd were trading at Rs 168.70 per scrip on BSE, up 5.11 per cent from its previous close.