April 06, 2009
FDA accepts NDA for Zegerid tablets, a treatment for ulcers and GERDSantarus announced that the FDA has accepted for filing the company's New Drug Application (NDA) for a new tablet formulation to add to its Zegerid (omeprazole and sodium bicarbonate) family of prescription products. Currently marketed Zegerid products include both a capsule and powder for oral suspension. Both the capsules and oral suspension are indicated for short-term treatment of active benign gastric ulcer, active duodenal ulcer, erosive esophagitis (EE), symptomatic gastroesophageal reflux disease (GERD) and maintenance of healing of erosive esophagitis. Zegerid powder for oral suspension (40mg only) is also indicated to reduce risk of upper gastrointestinal (GI) bleed in critically ill patients.
For more information call (888) 778-0887 or visit www.Zegerid.com.