Zydus Lifesciences secures USFDA approval for heart drug

USDFA approval for Ivabradine Tablets 

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

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. Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of $136.5 million in the United States (IQVIA MAT October 2023). The group now has 382 approvals and has so far filed over 448 ANDAs since the commencement of the filing process in FY 2003-04.

Company profile 

Zydus Lifesciences Ltd is a prominent integrated pharmaceutical company operating across the entire value chain, from research and development to the marketing and distribution of pharmaceutical products. With a diverse product portfolio encompassing Active Pharmaceutical Ingredients (API) and human formulations, the company’s focus extends to New Chemical Entities (NCE), biologics, vaccines, speciality and complex generic formulations, and API process development. Its global presence spans the United States, India, Europe, and emerging markets in Latin America, Asia Pacific, and Africa.

Stock price movement 

On Friday, Zydus Lifesciences closed at Rs 640, up by 0.34% from its previous closing of Rs 637.85 on the BSE. Today, the stock opened at Rs 640 and has touched a high and low of Rs 648.70 and Rs 637.20, respectively. The BSE group ‘A’ stock of face value of Rs 1 has a 52-week high and low of Rs 668.50 and Rs 401.05, respectively. Last one week high and low of the scrip stood at Rs 648.70 and Rs 628.05, respectively. The current market cap of the company is Rs 64,781.06 crore.

The promoters holding in the company stood at 74.98%, while Institutions and Non-Institutions held 17.95% and 7.07%, respectively.

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