HEALTH

Schering-Plough launches non-drowsy Claritin Liqui-Gels for allergies

BY Michael Johnsen

KENILWORTH, N.J. Schering-Plough Corporation on Wednesday launched Claritin Liqui-Gels, the first and only non-drowsy allergy medicine in an easy-to-swallow liquid-filled capsule.

“New Claritin Liqui-Gels is the latest advancement for the 50 million Americans who suffer from allergies,” said John O’Mullane, group vice president, research and development, Schering-Plough Consumer Health Care. “We are pleased to bring this innovative form to the line of non-drowsy Claritin products.”

A recent survey found that 75 percent of consumers who use liquid-filled capsules prefer them over tablets.

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HEALTH

FDA remains silent on decision regarding Zegerid

BY Michael Johnsen

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.

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FDA raises questions about Schering-Plough’s application for Zegerid

BY Michael Johnsen

SAN DIEGO Santarus on Tuesday announced that Schering-Plough HealthCare Products 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.

Santarus is in regular communication with Schering-Plough, the specialty pharmaceutical company said, adding that Schering-Plough intends to continue to work closely with the FDA on a confidential basis to expeditiously address these questions and secure approval of OTC Zegerid.

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.

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