The US Food and Drug Administration has failed to approve Valeant Pharmaceuticals International Inc’s (NYSE:VRX) new lotion for the treatment of plaque psoriasis.
In its complete response letter to Valeant laying out its decision, US health regulators posed questions regarding pharmacokinetic data, but did not specify any problems relating to the effectiveness or safety of Duobrii, the lotion.
The Canadian company has requested a meeting with the FDA and is working to resolve the matter as it looks to find a way to bring Duobrii to market.
In cases of plaque psoriasis, the most common type of its kind, the skin is red and inflamed and covered with silvery scales.
Valeant shares fell 12% to close at US$23.54, but the stock is still up roughly 76% over the last year.