ZegeridTreatment for Duodenal Ulcer, Gastroesophageal Reflux Disease, Gastric Ulcer, Erosive Esophagitis
Santarus Announces FDA Acceptance of New Drug Application For Zegerid Chewable Tablets
SAN DIEGO, July 26, 2005 - Santarus, Inc. (Nasdaq:SNTS), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's New Drug Application (NDA) for Zegerid (omeprazole) Chewable Tablets 40 mg and 20 mg. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Santarus expects the FDA will complete its review or otherwise respond to the Zegerid Chewable Tablets NDA by March 26, 2006. Santarus is seeking marketing approval of Zegerid Chewable Tablets as the first immediate-release proton pump inhibitor (PPI) in a chewable tablet formulation for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), erosive esophagitis, duodenal ulcers and gastric ulcers.
Santarus is currently marketing Zegerid Powder for Oral Suspension 40 mg and 20 mg, the first and only oral immediate-release PPI product which is rapidly absorbed (reaching peak plasma levels in approximately 30 minutes) and provides strong 24-hour acid control with once daily dosing. In late June, Santarus announced that the FDA had accepted for filing the company's NDA for Zegerid Capsules.
In connection with the FDA's acceptance for filing of the Zegerid Chewable Tablets NDA, Santarus provided notice to the NDA holder for Prilosec(R) delayed-release omeprazole capsules and related patent holders that Zegerid Chewable Tablets 40 mg and 20 mg do not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.
Source: Santarus, Inc.
Posted: July 2005
- Santarus Announces FDA Action Date of February 27, 2006 for Zegerid Capsules NDA - February 24, 2006
- Santarus Announces FDA Acceptance of New Drug Application For Zegerid Capsules; FDA Action Expected in Early 2006 on NDA for First Immediate-Release Proton Pump Inhibitor in Capsule Formulation - June 28, 2005
- Santarus Submits New Drug Application for Zegerid Chewable Tablets - May 27, 2005
- Santarus Submits New Drug Application for Zegerid Capsules; NDA for First Immediate-Release PPI Capsule Submitted Ahead of Previously Announced Third Quarter Target - April 28, 2005
- Zegerid Santarus, Inc. - Treatment for Heartburn/GERD, Erosive Esophagitis, Duodenal Ulcers - June 15, 2004
- FDA Accepts for Filing Santarus' New Drug Application for Rapinex Powder for Oral Suspension 40mg - April 29, 2004