CRN elects Mark LeDoux, Natural Alternatives International, chairman
WASHINGTON The Council for Responsible Nutrition on Monday announced that Mark LeDoux, CEO of Natural Alternatives International, has been elected CRN chairman. LeDoux, who will hold the office through 2010, succeeds Marjorie Fine, senior vice president and general counsel, Shaklee Corporation. Fine will continue to serve on the board as immediate past chair.
LeDoux has served as the chair-elect of the Board during 2007-2008, chair of the CRN Political Action Committee since its inception in 2004, and previously served as chair of the association’s International Trade and Market Development Committee.
“I have been an avid supporter of CRN for more than a decade and look forward to continuing the association’s aggressive agenda and initiatives,” said LeDoux. “During my two-year term, my goal is to strengthen CRN’s position as the responsible, leading voice of the dietary supplement industry. This association and its members are advocates for reasonable regulation that promotes unfettered consumer access anywhere in the world to well-made, properly labeled dietary supplements at any potencies that are demonstrated to be safe by appropriate scientific measures.”
With LeDoux, the following executives were newly named to the CRN board: chair-elect Janice Binger, Archer Daniels Midland Company; treasurer David Christensen, Bayer HealthCare; and secretary Kristen Blanchard, Nutramax Laboratories.
“This is a particularly strong board representing the diversity of the industry, with company representatives from large companies, small companies, ingredient suppliers, finished product manufacturers, pharmaceutical companies with supplement divisions and companies that make only natural products,” Steve Mister, CRN president and CEO, said. “Under [LeDoux’s] leadership, we expect to continue our growth and aggressive representation of the industry.”
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.
FDA raises questions about Schering-Plough’s application for Zegerid
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.