Glenmark Pharmaceuticals Receives USFDA Nod for Generic Mental Disorder Treatment

7 Nov 2023 , 10:55 AM

Glenmark Pharmaceuticals Ltd has received final approval from the US Food & Drug Administration (US FDA) for its generic Fluphenazine Hydrochloride tablets used in the treatment of specific mental disorders.

The approval covers Fluphenazine Hydrochloride tablets with strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg, according to a statement from Glenmark. These generic tablets are equivalent to Prolixin tablets of the same strengths produced by Apothecon Inc.

Glenmark Pharmaceuticals Inc, USA, will be responsible for distributing the company’s Fluphenazine Hydrochloride tablets in the United States.

Prolixin tablets, in strengths matching those of Glenmark’s generic versions, achieved approximately USD 18.1 million in annual sales for the 12 months ending in September 2023, based on IQVIA data cited by Glenmark.

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