BRIEF—FDA issues CRL on Duobrii

Ortho Dermatologics, a division of Canada’ s Valeant Pharmaceuticals International, today announced that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding the company's New Drug Application (NDA) for Duobrii (halobetasol propionate and tazarotene) (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 Papa, chairman and chief executive of 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," he added.