Tuesday, Santarus Inc. (SNTS) said the U.S. Food and Drug Administration or FDA approved Schering-Plough HealthCare Products, Inc.'s, New Drug Application or NDA for ZEGERID OTC Capsules with a dosage strength of 20 mg of omeprazole for over-the-counter treatment of frequent heartburn. Schering-Plough and Merck & Co., Inc. merged on November 3, 2009.
The NDA was submitted by Schering-Plough under the terms of a license agreement for OTC proton pump inhibitor or PPI products using Santarus' proprietary technology. Upon approval of ZEGERID OTC, Santarus earned a $20 million milestone and may be entitled to receive 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 ZEGERID OTC products sold by Schering-Plough HealthCare Products 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.
For comments and feedback: editorial@rttnews.com