FDA setback for S-P and Santarus' Zegerid
US drug major Schering-Plough has received a "complete response" letter from the Food and Drug Administration for Zegerid (omeprazole) 20mg, which the firm wants approved as an over-ther-counter treatment of heartburn.
The firm says the FDA has undisclosed questions regarding the application and intends to work closely with the agency on a confidential basis to expeditiously address the issues.
The New Drug Application for the OTC drug was submitted by Schering-Plough in March 2008 under the terms of a license agreement with Santarus.
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