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news.The FDA has accepted for review a new drug application from Santarus Inc, for a chewable form of the company's heartburn and reflux disease medicine, Zegerid.
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Santarus, a pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, expects the FDA will complete its review or give some response by March 26, 2006.
If the application is approved for marketing, the tablets will be the first immediate-release proton pump inhibitor (PPI) in a chewable tablet formulation for the treatment of heartburn and other symptoms associated with gastro-esophageal reflux disease (GERD), erosive esophagitis, duodenal ulcers and gastric ulcers.
A powder form of Zegerid that is dissolved in water and then drunk is already available on the market. Zegerid is absorbed into the blood stream, reaching peak plasma levels in approximately 30 minutes, and provides 24-hour acid control with once daily dosing.