Efinaconazole regulatory update

Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX, Mississauga, Ontario) said it received a complete response letter from FDA for an NDA for efinaconazole to treat onychomycosis. The company said FDA's questions pertain to CMC-related areas of the container closure apparatus and that the agency raised no efficacy or safety issues. Valeant requested a meeting with FDA to discuss the letter but did not disclose a timeline. Valeant has worldwide commercialization rights, excluding Japan, China, Taiwan and South Korea, to the topical triazole antifungal from Kaken. ...