The letter outlined questions that the FDA identified during its review of the new drug application (NDA) for over-the-counter (OTC) Zegerid.
Santarus said that it is in regular communication with Schering-Plough who intends to continue to work closely with the FDA on a confidential basis to expeditiously address these questions and secure approval of OTC Zegerid.
As previously disclosed, the NDA for OTC Zegerid was submitted by Schering-Plough in March 2008 under the terms of a licensing agreement signed in October 2006 for OTC proton pump inhibitor products using Santarus’s proprietary technology.