Zydus secures USFDA approval for Ivabradine tablets, shares up

Zydus Lifesciences Limited’s shares were up by 0.56 per cent after the company 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 approved to mitigate the risk of hospitalisation for worsening heart failure in adult patients with stable, symptomatic chronic heart failure featuring reduced left ventricular ejection fraction. Additionally, it is indicated for the treatment of stable symptomatic heart failure due to cardiomyopathy in children aged 6 months and older. The manufacturing of the drug will take place at the group’s formulation manufacturing facility in Ahmedabad SEZ, India.

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Zydus, among the initial ANDA applicants for Ivabradine Tablets, 5 mg, and 7.5 mg, may be eligible for 180 days of shared generic exclusivity, having submitted a complete ANDA with a paragraph IV certification. The drug had annual sales of USD 136.5 million in the United States (IQVIA MAT October 2023).

Zydus reported, with this approval, the company now holds a total of 382 approvals and has submitted over 448 ANDAs since the initiation of the filing process in FY04 as of 30th September 2023.

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