Zydus Lifesciences, on 1 December, announced that it had received final approval from the USFDA (United States Food and Drug Administration) for its tablets that are used in the prevention of heart failure.
In its exchange filing, the company said that it had received final approval from the US regulator to manufacture and market Ivabradine tablets in dosages of 5 mg and 7.5 mg.
The tablets are recommended to reduce the risk of hospitalisation for worsening heart conditions in adult patients who have stable and symptomatic chronic heart failure with reduced left ventricular ejection fraction.
The newly approved tablets are also used for children ranging from 6 years and above for the treatment of stable symptomatic heart failure due to cardiomyopathy.
The tablets will be manufactured at the company’s formulation manufacturing facility in Ahmedabad SEZ, India.
The Ivabradine Tablets 5 mg and 7.5 mg have an estimated sales of $136.5 million in the United States, according to IQVIA MAT data for October 2023.
The company was one of the first abbreviated new drug applications (ANDA) applicants to submit a substantially complete ANDA with a paragraph IV certification for Ivabradine Tablets, 5 mg and 7.5 mg and might also be eligible for 180 days of shared generic exclusivity for Ivabradine Tablets, 5 mg and 7.5 mg.
Till now, the company has received a total of 382 ANAD approvals and has filed for more than 448 ANAds since the process of its filing started in FY04.