Glenmark gets USFDA nod for generic version of Thorazine Tablets
Mumbai: Pharma major, Glenmark Pharmaceuticals Limited, today announced that the company has received final approval by the United States Food & Drug Administration (USFDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg.
The product is the generic version of Thorazine Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline.
Glenmark has been granted a competitive generic therapy (CGT) designation for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, therefore, with this approval, Glenmark is the first approved applicant for such competitive generic therapy and is eligible for 180 days of CGT exclusivity upon commercial marketing.
According to IQVIA sales data for the 12 month period ending January 2021, the Thorazine Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg market achieved annual sales of approximately $108.6 million*.
Glenmark's current portfolio consists of 171 products authorized for distribution in the U.S. marketplace and 41 ANDA's pending approval with the USFDA.
"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," the company said.
Glenmark Pharmaceuticals Ltd. is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.