Last Updated on June 25, 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.
USFDA approval granted for this Heartburn Capsules
USFDA approval granted for generic Letermovir Tablets
USFDA approval granted for the generic Lanreotide injection
USFDA approval granted for Asthma Treatment Drug
Medical Device recall: Unauthorized Plastic Syringes recalled
NDPS: Investigation started on Narcotic Abuse of Common Medications
USFDA inspection concluded at Lupin with zero observations
DPCO: Govt Fines Pharma Companies Over Rs 8,500 Crore
Medical Device recall: USFDA classifies recall of Catheter Kits as ‘most serious’
Govt Fast-Tracks Procurement of 120 Essential Drugs
USFDA issues Form 483 with 5 observations to Torrent Pharma
Gujarat FDCA: Pilot Project to Curb Antimicrobial Resistance launched
USFDA approval granted for this Heartburn Capsules
NPPA seeks data to fix ceiling prices of 138 drugs
9th Global Pharmaceutical Quality Summit to be hosted by IPA
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
