Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) for Duobrii1 (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 (Chemistry, Manufacturing, and Controls) 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.”
Valeant’s Ortho Dermatologics is a prescription dermatology business providing treatments for a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis, and other dermatoses. The Ortho Dermatologics portfolio includes several acne, anti-fungal, and anti-infective products.
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1 Provisional name
