WASHINGTON The Division of Gastroenterology Products of the Food and Drug Administration has approved the drug application for Wyeth’s Protonix in a delayed-release oral suspension.
The drug is indicated for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease, as well as maintenance of the healing of an erosive esophagitis.
“The availability of Protonix for delayed-release oral suspension provides adult patients who cannot swallow tablets with an effective and convenient way to treat their erosive gastroesophageal reflux disease,” says gastroenterologist Richard Lynn, senior director of global medical affairs for Wyeth Pharmaceuticals.
The recommended dosage for an adult patient is 40 mg daily for eight weeks, with an additional eight-week course that might be necessary depending on results.
In 2006, the drug generated $1.8 billion in total sales.