LAVAL, Quebec, June 18, 2018 /PRNewswire/ — Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX), today announced that it 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 DUOBRII™1 (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.”
About Ortho Dermatologics
Ortho Dermatologics, a Valeant Pharmaceuticals International, Inc. company, is one of the largest prescription dermatology businesses in the world dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Ortho Dermatologics portfolio includes several leading acne, anti-fungal and anti-infective products. More information can be found at www.ortho-dermatologics.com.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a global company whose mission is to improve people’s lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.valeant.com.
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1 Provisional name
*Chemistry, Manufacturing and Controls
DUOBRII is a trademark of Ortho Dermatologics’ affiliated entities.
© 2018 Valeant Pharmaceuticals North America LLC.