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Novartis Lamisil DermaGel

Executive Summary

Topical gel formulation of antifungal terbinafine approved April 29. NDA 20-846 provides for treatment of tinea versicolor due to Malassezia furfur (formerly Pityrosporum ovale), tinea pedis (athlete's foot) or tinea corporis (ringworm) due to Trichophyton rubrum, Trychophyton mentagrophytes, or Epidermophyton floccosum. Lamisil DermaGel does not carry an indication for tinea cruris (jock itch), which is included in Lamisil cream labeling...
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PS032116

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