Granules India gets approval from USFDA for selling Trospium Chloride extended-release capsules

Granules India has said that it has received a nod from the US Food and Drug Administration (USFDA) for marketing Trospium Chloride extended-release capsules.

FP Trending April 24, 2020 18:58:31 IST
Granules India gets approval from USFDA for selling Trospium Chloride extended-release capsules

Granules India has said that it has received a nod from the US Food and Drug Administration (USFDA) for marketing Trospium Chloride extended-release capsules.

Granules India gets approval from USFDA for selling Trospium Chloride extendedrelease capsules

Representational image. Reuters.

“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.

According to Dailymedwhich is the official provider of FDA label information, the drug is used in the treatment of overactive bladder (OAB). A sudden urge to urinate that's difficult to control is the symptom of this problem.

Doctors usually prescribe one 60 mg capsule of the drug daily in the morning. It should be taken with water on an empty stomach, at least one hour before a meal. The capsules are not recommended for the treatment of patients with severe renal impairment.

Trospium Chloride extended-release capsules are generic version of Allergan Inc''s Sanctura XR capsules.

Citing IQVIA Health, the drug firm said, “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.”

Granules India has received a total of 26 abbreviated new drug application (ANDA) approvals from the US drug regulator.

According to Moneycontrolthe drug firm’s share price witnessed a rise of six per cent in the early trade, after it received approval from the USFDA.

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