FDA approves Valeant's Jublia

LAVAL, Quebec — Valeant Pharmaceuticals International announced that its subsidiary, Valeant Pharmaceuticals North America, received approval from the Food and Drug Administration for its new drug application for Jublia (efinaconazole 10% topical solution). The drug is the first topical triazole approved for the treatment of onychomycosis of the toenails, the company said.



Onychomycosis is a common nail infection that is undertreated largely due to the limitations of available treatment options, Valeant said. Over-the-counter treatments provide limited efficacy and prescription oral treatments are limited because of drug interactions and other safety concerns.



"Onychomycosis is not only embarrassing and uncomfortable, but also can lead to permanent nail damage and limited mobility in the general population," said American Podiatric Medical Association Executive Director and CEO Glenn B. Gastwirth, DPM. "We welcome the approval of Jublia and encourage people with onychomycosis of the toenails to discuss their condition with their podiatrist or other healthcare professional to find a treatment that's right for them."  



Kraken Pharmaceutical, the licensor and business partner for efinaconazole, agreed to supply Valeant with the final dosage form of Jublia for the U.S. market.