East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Esomeprazole Magnesium for Delayed-Release Oral Suspension, 10 mg. Aurobindo Pharma’s Esomeprazole Magnesium for Delayed-Release Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), Nexium for Delayed-Release Oral Suspension manufactured by AstraZeneca Pharmaceuticals LP.

Esomeprazole Magnesium for Delayed-Release Oral Suspension are indicated for the following:

• Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age
• Maintenance of healing of EE in adults
• Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age
• Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers
• Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin
• Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults
• Short-term treatment in the healing of EE in pediatric patients 1 year to 11 years of age and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age
• Short-term treatment of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age.