Zydus gets USFDA approval for Prochlorperazine Maleate tablets

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Prochlorperazine Maleate tablets, USP 5 mg and 10 mg. Prochlorperazine Maleate tablets are used to treat nervous, emotional, and mental conditions (eg. schizophrenia) and non-psychotic anxiety. It is also used to control severe nausea and vomiting.

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India. Prochlorperazine Maleate tablets had annual sales of $30 million in the United States according to IQVIA MAT June 2022. The group now has 320 approvals since the commencement of the filing process in FY 2003-04.