Complete Response Letter regarding the New Drug Application (NDA) for DUOBRII (IDP-118) lotion in the treatment of plaque psoriasis. - Ortho Dermatologics/Valeant Pharma.
Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. announced that it has received a Complete Response Letter (CRL) from the 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 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."
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