Glenmark Pharma gets USFDA nod for Diltiazem Hydrochloride ER Capsules
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Mumbai: Drug major, Glenmark Pharmaceuticals Limited, today announced that the company has received final approval by the United States Food & Drug Administration (USFDA) for Diltiazem Hydrochloride Extended‐Release Capsules USP, 60 mg, 90 mg, and 120 mg.
The product is the generic version of Cardizem SR Extended‐Release Capsules, 60 mg, 90 mg, and 120 mg, of Biovail Laboratories Inc.
Glenmark 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.
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