Glenmark receives USFDA approval for Chlorpromazine Hydrochloride Tablets

Glenmark Pharmaceuticals has received 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 generic version of Thorazine1 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 IQVIATM sales data for the 12 month period ending January 2021, the Thorazine1 Tablets, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg market achieved annual sales of approximately $108.6 million.

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