Granules India receives USFDA approval for Bupropion Hydrochloride ER Tablets

3 Feb 2022 , 01:58 PM

Granules India announced today 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 the company, for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg. It is bioequivalent to the reference listed drug product, Wellbutrin XL Extended-Release Tablets, 150 mg and 300 mg, of Bausch Health US, LLC.

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

The current annual U.S. market for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg is approximately $661 Million, according to MAT Dec 2021, IQVIA/IMS Health.

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