Hot Pursuit     01-Dec-23
Zydus Life gets USFDA nod for Ivabradine tablets
Zydus Lifesciences announced that it has received final approval from the United States Food and Drug Administration (USFDA) for Ivabradine tablets.

Ivabradine is indicated to reduce the risk of hospitalization 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 6 months and older for the treatment of stable symptomatic heart failure due to cardiomyopathy. The said drug is equivalent to reference listed drug, Corlanor tablets.

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Zydus stated that it was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Ivabradine tablets and therefore may be eligible for 180 days of shared generic exclusivity for the same.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company consolidated net profit surged 53.2% to Rs 800.7 crore in Q2 FY24 as compared with Rs 522.5 crore posted in Q2 FY23. Revenue from operations rose 9.1% YoY to Rs 4,368.8 crore during the quarter ended 30 September 2023.

The scrip rose 0.31% to currently trade at Rs 639.85 on the BSE.

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