Schering-Plough answers FDA on Zegerid
This article was originally published in The Tan Sheet
Executive Summary
The proton pump inhibitor's licensee responds to the agency's January complete response letter that detailed concerns about making Zegerid available OTC, according to drug originator Santarus June 9. Zegerid (omeprazole 20 mg/sodium bicarbonate) would likely face an increasingly crowded OTC PPI market, since FDA approved Novartis'/Takeda Pharmaceuticals' yet-to-launch Prevacid 24HR (lansoprazole 15 mg) in May (1"The Tan Sheet" May 18, 2009, p. 3)