Glenmark Pharmaceuticals gets FDA final approval for Compazine generic

Glenmark Pharmaceuticals has bagged final approval for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg from the US Food & Drug Administration (FDA).

The approved product is the generic version of GlaxoSmithKline‘s Compazine Tablets, 5 mg and 10 mg. Compazine is indicated for the treatment of nausea, schizophrenia, migraines, anxiety, and psychosis.

Glenmark Pharmaceuticals said that the Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg will be distributed by its subsidiary Glenmark Pharmaceuticals Inc., USA in the US.

As per IQVIA sales data for the 12-month period ending January 2023, the annual sales of Compazine Tablets, 5 mg and 10 mg was around $26.9 million.

Glenmark Pharmaceuticals said that its present portfolio includes 182 products authorized for distribution in the American market and 46 abbreviated new drug applications (ANDAs) pending approval with the FDA.

Last week, Glenmark Pharmaceuticals said that its subsidiary Glenmark Specialty got the necessary clearance to start a first-in-human, phase 1/2 clinical study in the US of GRC 54276 for the treatment of advanced solid tumors and lymphomas.