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.
You may also be interested in...
Prilosec 1 Switch For Heartburn Prevention, 14-Day Use To Be Considered
OTC omeprazole will return for a second FDA advisory committee review June 21 with a revised indication and recommended duration of use
Prilosec 1 Switch For Heartburn Prevention, 14-Day Use To Be Considered
OTC omeprazole will return for a second FDA advisory committee review June 21 with a revised indication and recommended duration of use
Prilosec 1 Switch For Heartburn Prevention, 14-Day Use To Be Considered
OTC omeprazole will return for a second FDA advisory committee review June 21 with a revised indication and recommended duration of use