USFDA approval granted for Azilsartan Medoxomil, Chlorthalidone tablets

This tentative USFDA approval positions Zydus to capture a significant share of this market.

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USFDA Drug product Approval
USFDA Approval

Last Updated on June 28, 2024 by The Health Master

USFDA approval

Indian pharmaceutical giant Zydus Lifesciences has secured a significant win with tentative USFDA approval from the US Food and Drug Administration (USFDA) to market Azilsartan Medoxomil and Chlorthalidone tablets.

This USFDA approval represents a major opportunity for Zydus to tap into the lucrative US market for hypertension medication.

Treating High Blood Pressure with a Powerful Combination

The USFDA approved medication is a generic version of Edarbyclor tablets and combines two effective ingredients:

  • Azilsartan Medoxomil: An angiotensin II receptor blocker (ARB), which works by relaxing blood vessels to allow blood to flow more easily.
  • Chlorthalidone: A thiazide-like diuretic, which helps the body eliminate excess fluid through urination, reducing blood pressure.

This powerful combination effectively lowers blood pressure, making it a valuable treatment option for patients suffering from hypertension.

Addressing a Massive Market Gap

Zydus Lifesciences highlights the significant market potential for this medication.

According to IQVIA MAT March 2024 data, Azilsartan Medoxomil and Chlorthalidone tablets generated a staggering $77.9 million in annual sales within the US alone.

This tentative USFDA approval positions Zydus to capture a significant share of this market.

Zydus Poised for US Expansion

The USFDA approval for Azilsartan Medoxomil and Chlorthalidone tablets signifies Zydus Lifesciences’ growing presence in the US market.

The medication will be manufactured at the company’s state-of-the-art formulation facility in Ahmedabad SEZ-II, India, ensuring consistent quality and supply for American patients.

Looking Ahead: A Promising Future for Zydus

This USFDA approval is a major milestone for Zydus Lifesciences.

It opens doors for the company to expand its reach in the US market and contribute to providing patients with affordable and effective treatment options for hypertension, a prevalent health concern.

With its proven manufacturing capabilities and a strong product portfolio, Zydus is well-positioned for continued success in the years to come.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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