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www.fdanews.com/articles/73857-fda-accepts-santarus-s-nda-for-zegerid-capsules

FDA ACCEPTS SANTARUS'S NDA FOR ZEGERID CAPSULES

June 29, 2005

Santarus announced that the FDA has accepted for filing the company's new drug application (NDA) for Zegerid (omeprazole) capsules in 20- and 40-mg dosage forms.

Pursuant to Prescription Drug User Fee Act guidelines, Santarus expects the FDA will complete its review or otherwise respond to the Zegerid NDA by Feb. 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, erosive esophagitis, duodenal ulcers and gastric ulcers.

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.