JANSSEN LETTER TO P&T COMMITTEE SEEKING UNRESTRICTED STATUS FOR SPORANOX MISREPRESENTS CURE RATES, DDMAC SAYS; COMPARISON TO LAMISIL "UNSUBSTANTIATED"
Executive Summary
A letter that Janssen reps allegedly disseminated to a Pharmacy and Therapeutics committee requesting "unrestricted" status for Sporanox (itraconazole capsules) falsely claims clinical cure rates of 70% to 84% in the treatment of onychomycosis, FDA's Division of Drug Marketing, Advertising and Communications states in a March 27 letter to the company.