Santarus Submits New Drug Application for Zegerid Chewable Tablets
Santarus has submitted a new drug application for Zegerid chewable tablets 40 mg and 20 mg to the FDA.
The company is seeking marketing approval of Zegerid (omeprazole) 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, 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. Zegerid powder for oral suspension is rapidly absorbed (reaching peak plasma levels in approximately 30 minutes) and has strong 24-hour acid control with once-a-day dosing.
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