 "Glenmark Pharmaceuticals")
Global pharmaceutical company Glenmark Pharmaceuticals on Tuesday received the final approval for Fluphenazine Hydrochloride Tablets USP in four different strengths: 1 mg, 2.5 mg, 5 mg, and 10 mg from the United States Food and Drug Administration (U.S. FDA). These tablets represent the generic version of Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, originally manufactured by Apothecon. Glenmark will oversee the distribution of these tablets in the U.S. market through Glenmark Pharmaceuticals USA.
Prolixin is a prescription medication used to treat schizophrenia and other mental/mood disorders. It works by blocking the effects of dopamine, a substance that helps regulate mood, behaviour, and thoughts. According to IQVIA sales data for the 12-month period ending in September 2023, the Prolixin Tablets, in their various strengths, achieved annual sales of approximately $18.1 million.
Glenmark's current portfolio comprises 189 products authorised for distribution in the U.S, and an additional 50 Abbreviated New Drug Applications (ANDAs) are currently awaiting approval from the U.S. FDA. In its ongoing pursuit of growth and innovation, the company is also actively seeking external development partnerships to complement and accelerate the expansion of its existing pipeline and portfolio.
