Zydus Lifesciences gets USFDA approval for Esomeprazole Magnesium

8 Jun 2023 , 02:04 PM

Zydus Lifesciences Limited informed that the United States Food and Drug Administration (USFDA) has granted final approval for Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, and 40 mg.

Esomeprazole is a medication used to treat stomach and esophageal problems (such as acid reflux and ulcers). It functions by reducing the amount of acid produced by your stomach. It alleviates symptoms like heartburn, difficulty swallowing, and coughing.

This medication aids in the healing of acid damage to the stomach and esophagus, the prevention of ulcers, and the prevention of Esophageal cancer.

Esomeprazole belongs to the proton pump inhibitor (PPI) class of drugs. The company will manufacture the product at the group’s formulation facility located in Moraiya, Ahmedabad (India).

In the United States, Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, and 40 mg had annual sales of USD 42 million, as per IQVIA MAT April 2023.

Since the beginning of the filing process in FY 2003-04, the group has received 370 approvals and has filed over 442* ANDAs.

At around 1.55 PM, Zydus Lifesciences was trading 0.19% lower at Rs 514.10 against the previous close of Rs 515.10 on NSE.

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