Zydus gets US FDA final approval for Ivabradine Tablets, 5 mg and 7.5 mg

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Ivabradine Tablets, 5 mg and 7.5 mg (USRLD: Corlanor Tablets, 5 mg and 7.5 mg).

Ivabradine is indicated to reduce the risk of hospitalisation for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. It is also used in children aged six months and older for the treatment of stable symptomatic heart failure due to cardiomyopathy. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Ivabradine Tablets, 5 mg and 7.5 mg and therefore may be eligible for 180 days of shared generic exclusivity for Ivabradine Tablets, 5 mg and 7.5 mg.

Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of $136.5 million in the United States (IQVIA MAT October,2023).

The group now has 382 approvals and has so far filed over 448* ANDAs since the commencement of the filing process in FY 2003-04.