Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, the generic version of Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, of Apothecon. Glenmark’s Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, will be distributed in the US by Glenmark Pharmaceuticals US.
According to IQVIA sales data for the 12‐month period ending September 2023, the Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg market achieved annual sales of approximately $18.1 million*.
Glenmark’s current portfolio consists of 189 products authorised for distribution in the U.S. marketplace and 50 ANDAs pending approval with the US FDA.