Granules gets USFDA nod for antidepressant drug

Hyderabad: Hyderabad-based Granules India said 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 […]

Hyderabad: Hyderabad-based Granules India said 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 to treat major depressive disorder and seasonal affective disorder.

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Commenting on the approval Priyanka Chigurupati, ED, GPI, said “This product will be a valuable addition to our growing modified release product portfolio in the US market. The approval stands as a testimonial for our research and project management competence.”
Granules now have a total of 50 ANDA approvals from US FDA (48 Final approvals and 2 tentative approvals).

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

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