Glenmark Pharmaceuticals Receives USFDA Approval for Generic Mental Disorder Drug
Glenmark Pharmaceuticals Ltd announced on Tuesday that it has obtained final approval from the US Food & Drug Administration (USFDA) for its generic Fluphenazine Hydrochloride tablets, which are utilized in the treatment of specific mental disorders. According to Glenmark’s statement, the approval covers Fluphenazine Hydrochloride tablets with strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg.
These generic tablets are the counterparts of Prolixin tablets in identical strengths manufactured by Apothecon Inc., the statement further mentioned. Glenmark Pharmaceuticals Inc, USA, will oversee the distribution of the company’s Fluphenazine Hydrochloride tablets in the United States.
Glenmark reported that Prolixin tablets achieved annual sales of approximately USD 18.1 million for the 12 months ending September 2023, as per IQVIA data.