USFDA okays Granules Pharma Bupropion Hydrochloride ER Tablets

Hyderabad: Granules India Limited has recently announced that the US Food & Drug Administration (USFDA) 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).

Major depressive disorder is diagnosed when a person has a continuous low or depressed mood, anhedonia or lack of interest in activities, feelings of guilt or worthlessness, lack of energy, poor concentration, appetite changes, psychomotor retardation or agitation, sleep disturbances, or suicidal thoughts.

Commenting on the approval Ms. Priyanka Chigurupati, Executive Director, GPI, said "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. 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 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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