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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)

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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)

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