Zegerid decision could arrive in December

FDA schedules a December 2009 "action date" for Schering-Plough's Rx-to-OTC switch application for the proton pump inhibitor, Zegerid innovator Santarus says June 23. An FDA spokeswoman declined to say if an action might mean something other than an approval or denial. Schering, which licenses OTC Zegerid (omeprazole 20 mg/sodium bicarbonate), said it responded to FDA concerns about the switch application (1"The Tan Sheet" June 15, 2009, In Brief). If FDA approves a Zegerid switch, the drug would likely be the third branded OTC PPI on the market following Prilosec OTC (omeprazole 20 mg) and Prevacid 24HR (lansoprazole 15 mg). FDA granted Prevacid's switch in May and Novartis aims to ship in 2009 (2"The Tan Sheet" May 18, 2009)