East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Famotidine for Oral Suspension USP, 40 mg/5 mL. Aurobindo Pharma’s Famotidine for Oral Suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), Pepcid for Oral Suspension manufactured by Salix Pharmaceuticals, Inc.

Famotidine for Oral Suspension are indicated in:

• Adults for the treatment of:
  • Active duodenal ulcer (DU).
  • Active gastric ulcer (GU).
  • Symptomatic nonerosive gastroesophageal reflux disease (GERD).
  • Erosive esophagitis due to GERD, diagnosed by biopsy.
  • Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
  • Reduction of the risk of duodenal ulcer recurrence.
• Pediatric patients 1 year of age and older for the treatment of:
  • Peptic ulcer disease.
  • GERD with or without esophagitis and ulcerations.
• Pediatric patients from birth to less than 1 year of age for the treatment of:
  • GERD.