LAVAL, Quebec, Aug. 15, 2018 /CNW/ -- Ortho Dermatologics, a division of Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for DUOBRII™1 (halobetasol propionate and tazarotene) (IDP-118) lotion in the treatment of plaque psoriasis.
"After meeting with the FDA and understanding the additional pharmacokinetic data required for DUOBRII, we have resubmitted the NDA ahead of schedule," said Joseph C. Papa, chairman and CEO, Bausch Health. "We continue to have confidence in an approval of DUOBRII and hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible."
If approved, DUOBRII will be the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, allowing for a potentially expanded duration of use.
About Ortho Dermatologics Ortho Dermatologics, a Bausch Health 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 actinic keratosis, acne, atopic dermatitis, cold sores, athlete's foot, nail fungus and other dermatoses. The Ortho Dermatologics portfolio includes several leading acne, antifungal and anti-infective products. More information can be found at www.ortho-dermatologics.com.
About Bausch Health Bausch Health Companies Inc. (NYSE/TSX: BHC) 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.bauschhealth.com.
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