Glenmark Pharma gets USFDA’s approval for Diltiazem Hydrochloride Extended-Release Capsules

23 Mar 2021 Evaluate

Glenmark Pharmaceuticals has received final approval from the United States Food & Drug Administration (USFDA) for Diltiazem Hydrochloride Extended?Release Capsules USP, 60 mg, 90 mg, and 120 mg, the generic version of Cardizem SR Extended?Release Capsules, 60 mg, 90 mg, and 120 mg, of Biovail Laboratories Inc.

The company has been granted a competitive generic therapy (CGT) designation for Diltiazem Hydrochloride Extended?Release Capsules USP, 60 mg, 90 mg, and 120 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 months period ending January 2021, the Cardizem SR Extended?Release Capsules, 60 mg, 90 mg, and 120 mg market2 achieved annual sales of approximately $56.7 million. Glenmark’s current portfolio consists of 170 products authorized for distribution in the U.S. marketplace and 42 ANDA’s pending approval with the USFDA.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.

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