Valeant Pharmaceuticals (VRX) : psoriasis treatment rejection by FDA

• Note: Valeant Pharma (VRX) has been renamed Bausch Health (NYSE:BHC)  (July 2018)

 

 Valeant Pharma receives Complete Response Letter (CRL) regarding the New Drug Application for DUOBRII (IDP-118) lotion in the treatment of plaque psoriasis
"The CRL did not specify any deficiencies related to the clinical efficacy or safety of DUOBRII and no issues with CMC* processes. The CRL only noted questions regarding pharmacokinetic data," said Joseph C. Papa, chairman and CEO, Valeant. "We are working to resolve this matter expeditiously and have already requested a meeting with the FDA. We hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible."