uestions for NDAC/DODAC
May 6-7, 2004
antifungal drug development programs for tinea pedis evaluate safety and
efficacy at different concentrations, dosing durations, and dosing frequencies?
of symptom relief
discontinue drug use (especially in a setting where symptoms may persist beyond
the recommended duration of treatment)
Please discuss your
view of whether the phrase “cures most” is informative and accurate in OTC
antifungal drug resistance be a concern given the cure rates observed
in the clinical trials ?
Should antifungal MICs be determined for
clinical isolates during drug development and submitted with the NDA?
Is the risk of secondary infections (e.g.,
bacterial cellulitis), related to inadequately treated tinea pedis, of sufficient
frequency and severity as to merit communication in OTC consumer labeling? If so, what message should be crafted into