Zydus Receives Tentative Approval From USFDA for Azilsartan Medoxomil Tablets, 40 Mg And 80 Mg

On July 4, 2024, Zydus Lifesciences Limited, including its subsidiaries and affiliates (referred to as “Zydus”), received preliminary approval from the USFDA (US Food and Drug Administration) to market Azilsartan Medoxomil Tablets in 40 mg and 80 mg strengths (branded in the US as Edarbi® tablets).

Azilsartan is an angiotensin II receptor blocker (ARB) used to treat hypertension by lowering blood pressure. Therefore, it helps in minimising the risk of cardiovascular events like strokes and heart attacks. These tablets can be used alone or with other antihypertensive medications.

Production will occur at their manufacturing facility in Ahmedabad SEZ—II, India. Azilsartan Medoxomil Tablets recorded annual sales of USD 89 million in the United States as of March 2024 (IQVIA MAT). As of March 31 2024, Zydus has obtained 398 approvals and submitted over 460 ANDAs since initiating the filing process in FY 2003-04.

Recent Agreement

In their recent press release on June 28, 2024, Zydus Lifesciences Limited and Dr Reddy’s Laboratories Ltd announced a partnership to co-market a biosimilar of Pertuzumab in India. Pertuzumab is crucial for treating HER2-positive breast cancer. HER2 is a protein that stimulates cell growth and division. Some cancers produce excessive HER2 protein, known as HER2-positive cancers, which can spread rapidly without effective treatment. The biosimilar was developed internally by the Zydus Research Centre (ZRC). Under the agreement, Dr Reddy gains semi-exclusive rights from Zydus to market the product in India.

Zydus will sell it as Sigrima™, while Dr Reddy’s will market it as Womab®. Zydus will receive upfront licensing fees and could earn additional milestone payments based on specific achievements.

About Zydus Lifesciences Ltd

Zydus Lifesciences Limited (Zydus) is a leading Indian pharmaceutical company that develops and sells various pharmaceutical products. It holds a strong market position in various areas, such as pain relief, heart health, urology, and antibiotics. The company also offers non-prescription health products. Zydus distributes its medicines through pharmacies, hospitals, and clinics across India and exports them globally. It operates in three main sectors: Pharmaceuticals, Active Ingredients, and Contract Manufacturing Services (CMS).

On July 04, 2024, the share price of Zydus Lifesciences Ltd opened at ₹1,104.95 and closed at ₹1,139.50 on the NSE.

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