Granules India Limited has said that the US Food and Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by its US arm Granules Pharmaceuticals, Inc (GPI) 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 of Bausch Health US, LLC. Bupropion Hydrochloride is used as an antidepressant medication to treat major depressive disorder and seasonal affective disorder.
The current annual US 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.
“We have received approval 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,” Priyanka Chigurupati, Executive Director, GPI, said in a statement on Thursday.
Granules now have a total of 50 ANDA (48 final approvals and two tentative approvals) approvals from US FDA.