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news.Santarus has announced that Schering-Plough HealthCare Products has submitted a new drug application to the FDA for a Zegerid branded omeprazole or sodium bicarbonate product in a 20mg dosage strength of omeprazole.
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Schering-Plough is seeking FDA approval to sell the product in the US over-the-counter (OTC) heartburn market. The NDA was submitted under the terms of a license agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’s proprietary technology. Under that agreement, Santarus is entitled to receive up to an additional $22.5 million in regulatory milestones and up to an additional $37.5 million in sales milestones.
Santarus will also be entitled to a low double-digit royalty, subject to adjustment in certain circumstances, on net sales of any OTC products sold by Schering-Plough under the license agreement. In turn, Santarus will be obligated to pay royalties to the University of Missouri on net sales of any such OTC products.