Xenical Rx-To-OTC Switch Filing Slated For This Year
This article was originally published in The Pink Sheet Daily
Executive Summary
A 2005 filing for over-the-counter sale of the obesity agent would be one year earlier than previously expected. GlaxoSmithKline has conducted double-blind, placebo-controlled trials with an orlistat 60 mg dose and has received “good encouragement” from FDA, CEO Garnier says.
You may also be interested in...
GSK Begins Detailing Xenical Ahead Of OTC Switch Opportunity
GlaxoSmithKline's Consumer Healthcare division will detail the weight-loss therapy, focusing on diabetes risk reduction data recently added to labeling. Xenical was last detailed by Roche in November 2003. The Rx-to-OTC application is planned for mid-year.
GSK Begins Detailing Xenical Ahead Of OTC Switch Opportunity
GlaxoSmithKline's Consumer Healthcare division will detail the weight-loss therapy, focusing on diabetes risk reduction data recently added to labeling. Xenical was last detailed by Roche in November 2003. The Rx-to-OTC application is planned for mid-year.
Lotensin, Xenical, Brevibloc Need Continued Pediatric AE Monitoring – Committee
FDA's Pediatric Advisory Committee recommends continued monitoring for an additional year of pediatric adverse events associated with Novartis' anti-hypertensive Lotensin