Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Esomeprazole Magnesium for Delayed-Release Oral Suspension (20 mg and 40 mg), the company announced through an exchange filing.
The product will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad. Esomeprazole Magnesium for Delayed-Release Oral Suspension (20 mg and 40 mg) had annual sales of USD 42 million in the United States.
According to the press release, Esomeprazole is used to treat certain stomach and esophagus problems (such as acid reflux and ulcer). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers and is expected to help prevent cancer of the esophagus.
The group now has 370 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
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