FDA setback for S-P and Santarus' Zegerid

19 January 2009

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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