Zelmac Cost Analysis Data Could Define Use - Committee Member
Maintenance studies for Novartis' Zelmac should include a cost analysis component, FDA Gastrointestinal Drugs Advisory Committee member Michael Wolfe, MD, said June 26.
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FDA will have to decide between a high dose or titrated regimen for Novartis' irritable bowel syndrome therapy Zelmac following a review by the Gastrointestinal Drugs Advisory Committee.
Glaxo Wellcome Lotronex marketing materials "contain unsubstantiated Health-Related Quality of Life, productivity and economic claims" not adequately supported by clinical studies, FDA charged in an April 28 letter from the agency's Division of Drug Marketing, Advertising & Communications.
The recommended indication for Glaxo Wellcome's irritable bowel syndrome therapy Lotronex would cover about one-third of the U.S. IBS population.