BioCentury
ARTICLE | Clinical News

Jublia efinaconazole regulatory update

October 7, 2013 7:00 AM UTC

Marketing partner Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX, Montreal, Quebec) said Health Canada approved an NDS for Jublia efinaconazole to treat mild to moderate onychomycosis. Valeant said it has not set a launch date. Canada is the first to approve the topical triazole antifungal. Valeant has worldwide commercialization rights, excluding Japan, China, Taiwan and South Korea, to efinaconazole from Kaken. In May, Valeant said it received a complete response letter from FDA for an NDA for efinaconazole to treat onychomycosis (see BioCentury, June 3). ...