Valeant Pharmaceuticals receives Complete Response Letter from FDA for efinaconazole NDA

May 28 2013

Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for efinaconazole for the treatment of onychomycosis. A CRL is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. The questions raised by the FDA pertain only to Chemistry, Manufacturing and Controls (CMC) related areas of the container closure apparatus. As no efficacy or safety issues were raised by the FDA, Valeant believes that these items can be addressed and is working for a timely response to the FDA as soon as possible. Valeant remains committed to bringing efinaconazole to market as a potential new treatment for onychomycosis.