Glenmark Pharmaceuticals Ltd. on Monday said that it has received final approval by the United States Food & Drug Administration (U.S. FDA) for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the generic version of Compazine 1 Tablets, 5 mg and 10 mg, of GlaxoSmithKline. Glenmark’s Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
Prochlorperazine is a medication used to treat nausea, migraines, schizophrenia, psychosis, and anxiety. Reportedly, it is a less preferred medication for anxiety. It may be taken by mouth, rectally, injection into a vein, or injection into a muscle.
According to IQVIA TM sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market 2 achieved annual sales of approximately $26.9
million.
Glenmark’s current portfolio consists of 182 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.