Glenmark gets USFDA nod for generic drug used to treat mental disorder

Glenmark Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic Fluphenazine Hydrochloride tablets used to treat certain types of mental disorders. The approval granted by the US Food & Drug Administration (US FDA) is for Fluphenazine Hydrochloride tablets of strengths 1 mg, 2.5 mg, 5 mg and 10 mg, Glenmark said in a statement.

These are the generic versions of Prolixin tablets in same strengths of Apothecon Inc, it added.

The company's Fluphenazine Hydrochloride tablets will be distributed in the US by Glenmark Pharmaceuticals Inc, USA, it said.

For the 12 months ended September 2023, Prolixin tablets in the same strengths achieved annual sales of approximately USD 18.1 million, Glenmark said citing IQVIA data.

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