Santarus announces Schering-Plough response submission to FDA for OTC Zegerid

SAN DIEGO Santarus on Tuesday announced that Schering-Plough HealthCare Products received notification from the Food and Drug Administration of a December action date for its switch application of the proton-pump inhibitor Zegerid.

Schering-Plough submitted a New Drug Application in March 2008, seeking approval to sell Zegerid in the U.S. over-the-counter heartburn market. In January, Schering-Plough received a complete response letter from the FDA and submitted a response to that letter in early June.