Zydus Lifesciences Secures USFDA Approval for Diltiazem Hydrochloride Tablets
Ahmedabad – Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Diltiazem Hydrochloride Tablets USP in four strengths: 30 mg, 60 mg, 90 mg, and 120 mg. These are the generic equivalents of Cardizem® tablets in the US market.
Therapeutic Use and Drug Profile
-
Indication:
- Management of chronic stable angina
- Angina caused by coronary artery spasm -
Drug Class: Calcium-channel blocker
- Mechanism of Action:
- Relaxes blood vessels
- Reduces heart workload
- Improves blood and oxygen supply to the heart muscle
Manufacturing Details
- To be manufactured at Zydus Lifesciences Ltd., Baddi, Himachal Pradesh
- Part of the company’s expanding portfolio of USFDA-approved generics
Regulatory Milestone
- 423 cumulative USFDA approvals to date
- 483 ANDAs filed since the company began its submission process in FY 2003–04
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