Zydus gets U.S. FDA nod for Diltiazem Hydrochloride tablets

Generic drugmaker Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for Diltiazem Hydrochloride tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg.

A generic of Cardizem Tablets, the drug is indicated for management of chronic stable angina and angina due to coronary artery spasm. Diltiazem Hydrochloride tablets had annual sales of $13.9 million in the U.S., Zydus said, citing IQVIA MAT June 2025 numbers.

The approved drug will be produced at its plant in Baddi, Himachal Pradesh, the company said. Belonging to a class of drugs called calcium-channel blockers, Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle, it said.

Zydus Lifesciences shares closed 2.18% higher at ₹955.90 apiece on the BSE.