Marksans Pharma Announces US FDA Approval For Esomeprazole Magnesium Delayed-Release Capsules

Marksans Pharma Limited on Tuesday announced that it has received final approval from the US Food & Drugs Administration for its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), the company announced through an exchange filing.

This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR DelayedRelease Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals LP.

About Esomeprazole

Esomeprazole is used to treat certain stomach and esophagus problems "'(such as acid reflux ane 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. 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, India.

Marksans Pharma Limited shares

The shares of Marksans Pharma on Tuesday at 12:11 pm IST were at Rs 109.55, down by 0.45 percent.