Glenmark Pharma Gets U.S. FDA Nod To Market Generic Schizophrenia Tablets
The company has received nod from the U.S. Food and Drug Administration for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the Mumbai-based drug maker said in a statement.
Glenmark Pharmaceuticals Ltd. on Monday said it has received approval from the U.S. health regulator to market a generic product used to treat schizophrenia and, in some cases to control severe nausea.
The company has received the nod from the U.S. Food and Drug Administration for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the Mumbai-based drug maker said in a statement.
Glenmark Pharma's product is the generic version of GlaxoSmithKline Pharmaceuticals Ltd.'s Compazine tablets, it added.
According to IQVIA sales data for the 12-month period ending January 2023, the Compazine tablets (5 mg and 10 mg) achieved annual sales of around $26.9 million.
Glenmark said its current portfolio consists of 182 products authorised for distribution in the U.S. marketplace and 46 abbreviated new drug applications (ANDAs) pending approval with the U.S. FDA.