FDA Rejects Valeant's Efinaconazole for Onychomycosis

The FDA rejected Valeant Pharmaceuticals' New Drug Application for efinaconazole for the treatment of onychomycosis. The questions raised by the FDA that precluded the approval pertain only to Chemistry, Manufacturing and Controls areas of the container closure apparatus. As no efficacy or safety issues were raised by the FDA, Valeant hopes to address the issues as soon as possible.