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FDA Approves Protonix(R) pantoprazole sodium) for Delayed-Release Oral Suspension for Erosive Gastroesophageal Reflux Disease COLLEGEVILLE, PA -- November 16, 2007 -- The U.S. Food and Drug Administration (FDA) has approved Protonix(R) (pantoprazole sodium) for Delayed-Release Oral Suspension for treatment of erosive gastroesophageal reflux disease (GERD). The Protonix family of products includes Protonix Delayed-Release Tablets and Protonix I.V. For Injection. The new Protonix For Delayed-Release Oral Suspension provides comparable acid suppression to Protonix Tablets. Protonix For Delayed-Release Oral Suspension can be administered orally in applesauce or apple juice, or through a nasogastric (NG) tube. Protonix For Delayed-Release Oral Suspension is indicated for the treatment and maintenance of healing of erosive esophagitis with associated GERD symptoms. Controlled studies did not extend beyond 12 months. The adverse reaction profile of Protonix For Delayed-Release Oral Suspension is similar to the established safety profile of Protonix Delayed- Release Tablets. In clinical trials, the most frequently reported adverse events with Protonix Delayed-Release Tablets were headache, diarrhea, and flatulence. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Protonix is contraindicated in patients with known hypersensitivity to any component of the formulation. Patients treated with proton pump inhibitors (PPIs) and warfarin concomitantly should be monitored for increases in INR and prothrombin time. SOURCE: Wyeth Pharmaceuticals E-mail this page to a friend or colleague! To print, use this version