ZegeridTreatment for Duodenal Ulcer, Gastroesophageal Reflux Disease, Gastric Ulcer, Erosive Esophagitis
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
SAN DIEGO, June 28, 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) Capsules 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 Capsules NDA by February 26, 2006. Santarus is seeking marketing approval of Zegerid Capsules as the first immediate-release proton pump inhibitor (PPI) in a capsule formulation for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), erosive esophagitis, duodenal ulcers and gastric ulcers. Capsules are the most widely used dosage form within the PPI class of drugs.
"We believe that GERD patients may find our immediate-release capsules convenient for daily use and, subject to regulatory approval, commercialization of this formulation could broaden Zegerid usage," said Gerald T. Proehl, president and chief executive officer of Santarus. "Acceptance of our Zegerid Capsules NDA submission is an important step in reaching our goal to expand the Zegerid product family. We plan to offer three product formulations of immediate-release Zegerid, including powder for oral suspension, capsules and chewable tablets."
Santarus is currently marketing Zegerid Powder for Oral Suspension 40 mg and 20 mg, an 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 connection with the FDA's acceptance for filing of the Zegerid Capsules NDA, Santarus provided notice to the NDA holder for Prilosec delayed-release omeprazole capsules and related patent holders that Zegerid Capsules 40 mg and 20 mg do not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.
Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products to enhance the quality of life for patients with gastrointestinal diseases and disorders. The company's current products are immediate-release formulations of omeprazole, a widely prescribed PPI. The company launched its first product, Zegerid Powder for Oral Suspension 20 mg, in October 2004 and launched Zegerid Powder for Oral Suspension 40 mg in February 2005. The company submitted an NDA for Zegerid Capsules to the FDA in April 2005 and submitted an NDA for Zegerid Chewable Tablets to the FDA in May 2005.
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Posted: June 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 Chewable Tablets - July 26, 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