FDA remains silent on decision regarding Zegerid

SAN DIEGO Contrary to reports published early Tuesday, the Food and Drug Administration has given no indication as to which direction the agency is leaning in considering the over-the-counter switch application of the proton-pump inhibitor Zegerid.

Santarus Tuesday morning announced that Schering-Plough HealthCare Products—which has licensed the OTC rights of Zegerid from Santarus—recently received a Complete Response Letter from the Food and Drug Administration with questions on the proposed switch of Santarus’ prescription proton-pump inhibitor Zegerid.

Published reports earlier indicated that FDA “declined to approve” the switch application, suggesting that the FDA was leaning toward not approving OTC Zegerid.

As of August 2008, the FDA replaced its Approvable and Not Approvable letters with the Complete Response Letter. “A complete response letter provides a more consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form,” the FDA states on its Web site. “It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application.”

“We are and will continue to work closely with the FDA on the potential approval of OTC Zegerid,” Julie Lux, Schering-Plough spokeswoman, told Drug Store News. “We are continuing to work with them; obviously our ultimate goal is for approval of the compound for OTC.”

The NDA for OTC ZEGERID was submitted by Schering-Plough in March 2008. Schering-Plough licensed the OTC rights of Zegerid from Santarus in 2006.