Valeant Pharmaceuticals International (NYSE:VRX) (TSE:VRX) says that the U.S. FDA has remaining questions about the company's new drug application for efinaconazole - a drug designed for the treatment of onychomycosis, more commonly known as ringworm.
The company said Tuesday it has received a complete response letter from the U.S. health regulator, which is issued when questions remain that preclude the approval of the new drug application in its current form.
The questions relate to the chemistry, manufacturing and controls areas of the container closure apparatus, the company said, as no efficacy or safety issues were raised.
As a result, Valeant said it believes these concerns can be addressed and is working on respond to the FDA as soon as possible, remaining comitted to bringing efinaconazole to market.
The news follows the company's announcement yesterday, when it said it had inked an $8.7 billion cash deal to take over Bausch & Lomb Holdings Inc., the eye-care company owned by New York-based Warburg Pincus LLC.
The acquisition positions Valeant to capitalize on growing eye health trends driven by an aging patient population, an increased rate of diabetes and demand from emerging markets.
Shares of Valeant in Toronto were lately down by 0.6 per cent at $95.25, after climbing sharply on Monday after news of the acquisition. In New York, shares of Valeant were up by more than 8 per cent, as U.S. markets played catch-up after being closed Monday for the Memorial Day holiday.
Valeant develops, manufactures and markets a range of pharamceutical products, primarily in the areas of dermatology, neurology and branded generics.