Zydus Secures USFDA Final Approval For Ivabradine Tablets

The United States Food and Drug Administration (USFDA) has granted final clearance to Zydus Lifesciences 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, as per economic times. 

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.

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

In the United States, ivabradine tablets (5 mg and 7.5 mg) had yearly sales of $136.5 million (IQVIA MAT October,2023).

Zydus Lifesciences Limited, originally Cadila Healthcare Limited, is an Indian multinational pharmaceutical business based in Ahmedabad that mostly manufactures generic pharmaceuticals. In 2020, the firm was rated 100th on the Fortune India 500 list. Ramanbhai Patel, a former instructor at the L.M. College of Pharmacy, and his business partner Indravadan Modi created Cadila in 1952.