Glenmark Pharmaceuticals Receives FDA Approval For Fluphenazine Hydrochloride Tablets

Glenmark Pharmaceuticals received final approval by the United States Food & Drug Administration (U.S. FDA) for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, the generic version of Prolixin1 Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, of Apothecon Inc, the company informed in a press statement on Tuesday.

Fluphenazine Hydrochloride Tablets are used for their tranquillizer effect and are intended for the management of schizophrenia. 

Glenmark’s Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA, the company's statement informed.

According to IQVIATM sales data for the 12-month period ending September 2023, the Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg market2 achieved annual sales of approximately USD18.1 million.

Glenmark’s current portfolio consists of 189 products authorised for distribution in the U.S. marketplace and 50 ANDAs pending approval with the U.S. FDA, the company added.