Zegerid decision could arrive in December
This article was originally published in The Tan Sheet
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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Santarus expects OTC Zegerid in 2010: The proton pump inhibitor's originator expects Merck/Schering-Plough to launch OTC Zegerid, should FDA approve it, in the first half of 2010. FDA's action date on the Zegerid switch application is set for December (1"The Tan Sheet" June 29, 2009, In Brief). In its Nov. 4 earnings release, San Diego-based Santarus raised its fiscal 2009 revenue guidance to $150 million from $145 million, but expects challenging quarters ahead due to changes in the PPI market, including this month's planned launch of Novartis' OTC Prevacid 24HR. Santarus increased product-related revenues 29.8 percent to $38.3 million in the third quarter. Rx Zegerid sales grew 12.1 percent to $31.5 million
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)
Novartis plans to prioritize converting patients currently treated with prescription Prevacid when the proton pump inhibitor becomes available over-the-counter, rather than winning over Prilosec OTC users, a Novartis executive said