Marksans Pharma Limited informed the exchange that it had received final approval from the US Food & Drugs Administration for its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20mg(OTC).
This product is bioequivalent to the reference listed drug (RLD),Nexium24 HR Delayed Release Capsules, 2.0mg (OTC), of Astra Zeneca Pharmaceuticals LP.
Esomeprazole is used to treat certain stomach and esophagus problems such as acid reflux and ulcers.
It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty in 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. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).
The product will be manufactured at the Company’s formulation manufacturing facility in Goa.