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.
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