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Santarus Submits New Drug Application for Zegerid Capsules

April 29, 2005

Santarus has submitted a new drug application for Zegerid capsules 40 mg and 20 mg to the FDA.

The company is seeking marketing approval of Zegerid (omeprazole) 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.

The company is currently marketing Zegerid powder for oral suspension 40 mg and 20 mg, which is also an immediate-release PPI product and provides rapid absorption of the drug (reaching peak plasma levels in approximately 30 minutes) and strong 24-hour acid control with once-a-day dosing.