Granules India gets USFDA approval for generic antidepressant drug

Drug firm Granules India on Thursday said it has received approval from the US health regulator to market Bupropion Hydrochloride extended-release tablets, an antidepressant medication, in the American market.

Granules Pharmaceuticals, Inc (GPI), a wholly-owned subsidiary of the company, has received approval from the US Food & Drug Administration (USFDA) to market the product in strengths of 150 mg and 300 mg, the Hyderabad-based drug firm said in a statement.

The company's product is a generic version of Bausch Health US, LLC's Wellbutrin XL extended-release tablets.

Bupropion Hydrochloride is used as an antidepressant medication to treat major depressive disorder and seasonal affective disorder.

"We are pleased to receive approval of Bupropion Hydrochloride (XL) tablet product within first review cycle of 10 months from filing date. This product will be a valuable addition to our growing modified release product portfolio in the US market," GPI Executive Director Priyanka Chigurupati stated.

This product will be a valuable addition to the company's growing modified release product portfolio in the US market, she added.

According to MAT Dec 2021, IQVIA/IMS Health, the current annual US market for Bupropion Hydrochloride extended-release tablets is around USD 661 million.

Granules noted that it now has a total of 50 abbreviated new drug application (ANDA) approvals from the USFDA.