FDA Accepts NDA for ZEGERID Tablet
Mon, 04/06/2009 - 5:02am
SAN DIEGO-- (BUSINESS WIRE) — Santarus, Inc., a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's New Drug Application (NDA) for a new tablet formulation to add to its ZEGERID(R) family of branded prescription pharmaceutical products. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus expects the FDA will complete its review or otherwise respond to the NDA by December 4, 2009. The NDA was submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. In connection with the FDA's acceptance for filing of the NDA for a new tablet formulation, Santarus is providing notice to the NDA holder for Prilosec(R) (omeprazole) delayed-release capsules and related patent holders that the new tablet formulation does not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid. About Currently Marketed ZEGERID Prescription Products ZEGERID (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), maintenance of healing and short-term treatment of erosive esophagitis, and short-term treatment of active benign gastric ulcers and active duodenal ulcers. ZEGERID Powder for Oral Suspension 40 mg is also indicated for the reduction of risk of upper gastrointestinal bleeding in critically ill patients.