Zydus Lifesciences Receives USFDA Approval for Generic Heart Failure Treatment Drug

Ivabradine is designed to lower the likelihood of hospitalisation due to deteriorating heart failure in adults experiencing stable, symptomatic chronic heart conditions under specific circumstances, as stated by the company.

Zydus Lifesciences, a leading pharmaceutical player, has secured final approval from the US Food and Drug Administration (USFDA) for its generic version of Ivabradine tablets to treat heart failure. 

The approval applies to tablets with strengths of 5 mg and 7.5 mg, as confirmed in a recent regulatory filing by the company. In addition, the drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ, India.

Ivabradine, the approved drug, is designed to reduce the risk of hospitalisation for worsening heart failure in adults with stable, symptomatic chronic heart conditions. 

Moreover, it extends its utility to children aged six months and older for the treatment of stable symptomatic heart failure due to cardiomyopathy.

Zydus Lifesciences, among the early applicants for the abbreviated new drug application (ANDA), submitted a substantially complete ANDA with a paragraph IV certification for Ivabradine Tablets, 5 mg and 7.5 mg. 

This positions the company as a potential beneficiary of 180 days of shared generic exclusivity for the same.

Annual sales data from IQVIA MAT October 2023 reveals that Ivabradine tablets, 5 mg, and 7.5 mg collectively recorded sales of USD 136.5 million in the US market.

Established in 1952 by Ramanbhai B Patel, the company has evolved under the Zydus group, displaying substantial financial growth from a modest INR 250 Cr in 1995 to over INR 17,000 Cr in FY-21.

This approval follows Zydus Lifesciences' recent success with the United States Food and Drug Administration (USFDA) for Zituvimet, a drug addressing type-2 diabetes mellitus in adults. 

Zituvimet, a combination of sitagliptin and metformin hydrochloride, supplements diet and exercise for enhanced glycemic control in adults with type-2 diabetes mellitus.

In a parallel stride, in November,  Dr. Reddy's Laboratories Ltd introduced Nerivio, an advanced USFDA-approved wearable therapy device designed for drug-free migraine management in India. 

This prescription-based, non-invasive device caters to both acute and preventive treatment of migraines for adults and adolescents aged 12 years and above. Worn on the upper arm, Nerivio offers 18 sessions of 45 minutes each.