Drugmaker Zydus Lifesciences has received tentative approval from the U.S. Food and Drug Administration (FDA) to market Azilsartan Medoxomil and Chlorthalidone Tablets, 40 mg/12.5 mg and 40 mg/25 mg.
The approved product is a generic version of Edarbyclor tablets and is indicated for the treatment of high blood pressure (hypertension). Azilsartan Medoxomil and Chlorthalidone tablets had annual sales of $77.9 million in the U.S., Zydus said, citing IQVIA MAT March 24 numbers in a release on Friday.
The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ – II. The company’s shares rose 1.89% to close at ₹1,110.95 each on the BSE.
Edarbyclor is a trademark of Takeda Pharmaceutical Company and is registered with the U.S. Patent and Trademark Office.
