Prilosec 1 Switch For Heartburn Prevention, 14-Day Use To Be Considered
This article was originally published in The Tan Sheet
Executive Summary
OTC omeprazole will return for a second FDA advisory committee review June 21 with a revised indication and recommended duration of use
You may also be interested in...
Rx-To-OTC Consumer Purchase Trends To Be Tracked By ACNielsen
ACNielsen's U.S. Homescan Rx/OTC Consumer Panel will help the pharmaceutical industry monitor consumers' purchasing trends with regard to new switch drugs, the market research firm contends
ODE V Permanent Director Bull Brings Women’s Health, Analgesics Expertise
Jonca Bull, MD, will tackle Rx-to-OTC switch issues head-on in her first week as permanent director of FDA's Office of Drug Evaluation V
Pediatric studies meeting
Pediatric subcommittee of FDA's Anti-Infective Drugs Advisory Committee will meet in Bethesda, Md. June 11 to discuss list of drugs that have lost marketing exclusivity but need pediatric studies. Panel also will discuss a template for FDA "written requests" for pediatric studies of proton pump inhibitors in treating gastroesophageal reflux disease. AstraZeneca/P&G's NDA to switch the PPI Prilosec (omeprazole) OTC is focus of a joint Nonprescription Drugs/Gastrointestinal Drugs Advisory Committee meeting June 21 (1"The Tan Sheet" April 29, 2002, p. 3)...