Schering-Plough answers FDA on Zegerid
This article was originally published in The Tan Sheet
Executive SummaryThe 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)
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Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.