Detail aid comparing Lamisil (terbinafine) and itraconazole (Janssen/Ortho Biotech's Sporanox) presents selective data that is misleading, FDA maintains in a March 5 follow-up letter. The piece contains "only selected portions" of an abstract from a comparative study, which presents comparative mycological cure rates between the two treatments, but does "not prominently disclose that the mycological cure rate is not predictive of the total clinical cure rate, which may be lower." FDA also objects to a superiority claim in the treatment of toenail onychomycosis that compares an "approved use" of Lamisil with an "unapproved use" of Sporanox. A meeting with the agency to discuss the claims has been scheduled, the company said. Novartis also received recent letters for promotions of Migranal (dihydroergotamine) and Neoral (cyclosporine for microemulsion)
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