FDA Approves Prilosec OTC to Treat Frequent Heartburn

FDA Approves Prilosec OTC to Treat Frequent Heartburn

The Food and Drug Administration (FDA) today announced the approval of Prilosec OTC (omeprazole), the first over-the-counter treatment for frequent heartburn. Omeprazole, a proton pump inhibitor, is indicated for the treatment of heartburn that occurs two or more days per week. Prescription omeprazole is currently available for frequent heartburn and other related, but more serious, problems that need a physician’s care. FDA based its approval of omeprazole OTC on the results of efficacy studies. Prescription omeprazole, first approved by FDA in 1989, will remain available as a prescription treatment (but in the same dose as the OTC product) for diseases that require diagnosis and supervision by a doctor, such as gastroesophageal reflux disease, inflammation of the esophagus, and ulcers. This product will have three years of over-the-counter exclusivity, and generic versions of the prescription product will be ineligible to market an OTC version until the exclusivity has expired. AstraZeneca LP of Wilmington, DE, and Procter and Gamble of Cincinnati, OH, are the sponsors of the approved New Drug Application (NDA) for Prilosec OTC.

Source: FDA News—June 20, 2003