Santarus PPI could be future Merck switch
This article was originally published in The Tan Sheet
Executive Summary
Merck's Schering-Plough consumer products unit would have OTC switch rights to a Santarus dual-buffer prescription proton pump inhibitor if FDA approves it under the Zegerid brand. The agency approved Santarus' immediate-release omeprazole/sodium bicarbonate/magnesium hydroxide prescription drug for treatment of heartburn and other symptoms of gastroesophageal reflex disease in 20-mg and 40-mg doses, the San Diego firm said Dec. 4. If FDA approves a new drug application supplement requesting the drug's name include the Zegerid brand, as Santarus expects, Merck can apply to switch it to OTC, a Santarus spokeswoman said. The Rx announcement follows FDA's approval of Zegerid OTC, set to launch in 2010 (1"The Tan Sheet" Dec. 7, 2009)
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