Santarus, Inc. (SNTS) announced that Schering-Plough HealthCare Products, Inc. has received notification from the U.S. Food and Drug Administration of a December 2009 action date for an over-the-counter, or OTC, ZEGERID branded omeprazole/sodium bicarbonate product with the dosage strength of 20 mg of omeprazole. Schering-Plough submitted a New Drug Application in March 2008 seeking approval to sell ZEGERID in the U.S. OTC heartburn market.
Under the license agreement with Schering-Plough, Santarus is entitled to receive a $20-million milestone upon FDA approval of OTC ZEGERID, a low double-digit royalty on net sales of any OTC ZEGERID product, and may receive up to an additional $37.5 million in sales milestones.
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