Prilosec GERD Indication OTC Appropriateness Debated At NDAC Meeting
This article was originally published in The Tan Sheet
Executive Summary
Gastroesophageal reflux disease is appropriate for OTC treatment, but AstraZeneca/Procter & Gamble's NDA to switch Prilosec OTC is not approvable, FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees decided at a joint meeting in Gaithersburg, Md. Oct. 20.