Zydus gets USFDA nod for generic drug to treat stomach & esophagus problems

Zydus Lifesciences on Thursday said it has received approval from the US health regulator to market a generic drug used to treat certain stomach and esophagus problems.

The company has received approval from US Food and Drug Administration (USFDA) to market Esomeprazole Magnesium for delayed-release oral suspension in 20 mg and 40 mg strengths in the American market, the drug maker said in a statement.

Esomeprazole is used to treat certain stomach and esophagus problems such as acid reflux and ulcer. It works by reducing the amount of acid the stomach makes and providing relief from 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 product will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, Zydus Lifesciences said.

As per IQVIA MAT April 2023 data, Esomeprazole Magnesium for Delayed-Release Oral Suspension (20 mg and 40 mg) had annual sales of USD 42 million in the US.

Shares of Zydus Lifesciences ended 0.16 per cent down at Rs 514.20 apiece on the BSE.