18 June 2018 - Ortho Dermatologics, a division of Valeant Pharmaceuticals, today announced that it has received a complete response letter from the U.S. FDA regarding the company's New Drug Application (NDA) for Duobrii (halobetasol propionate and tazarotene) (IDP-118) lotion in the treatment of plaque psoriasis.

"The letter did not specify any deficiencies related to the clinical efficacy or safety of Duobrii and no issues with CMC processes. The letter 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."

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