Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced that that its wholly owned subsidiary, Valeant Pharmaceuticals North America LLC, received notice that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Jublia® (efinaconazole 10% topical solution), the first topical triazole approved for the treatment of onychomycosis of the toenails. "We acquired Jublia® through our purchase of Dow Pharmaceutical Sciences in 2008 and advanced Jublia® from pre-IND stage through Clinical Phases 1, 2 and 3," said J. Michael Pearson, chairman and chief executive officer. "We are working quickly to get this important product launched in the U.S. and Canada in the third quarter of 2014. We anticipate favorable managed care coverage in the U.S., similar to other branded antifungal agents, with peak sales of $300-$800 million in the U.S. alone and we are also working with other regulatory agencies around the world on further approvals. This is the fourth product, sourced from our acquisition of Dow Pharmaceutical Sciences, for which we have received FDA approval – the other three being 1% clindamycin and 5% benzoyl peroxide gel (IDP 111), Acanya® and Retin-A Micro (tretinoin) Gel microsphere 0.08%. We have also filed a new treatment for acne, Onexton™, which has a PDUFA date of November 30, 2014. All these compounds came through our Dow acquisition, bringing with it the full set of R&D capabilities from preclinical through regulatory."