US FDA Accepts Ortho Dermatologics Filing for Jemdel Plaque Psoriasis Treatment
20 February 2018 - - Ortho Dermatologics, a division of Laval, Quebec-based pharmaceutical and medical device company Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX), has been notified that the US Food and Drug Administration has accepted the new drug application for Jemdel (halobetasol propionate 0.01%; IDP-122) lotion, the company said.
The FDA has assigned a PDUFA action date of Oct. 5, 2018.
If approved, Jemdel will be the first high-potency topical steroid treatment for plaque psoriasis, a chronic, painful immune-mediated inflammatory skin disease, with dosing for as long as eight weeks.
Ortho Dermatologics is dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. Its portfolio includes several leading acne, anti-fungal and anti-infective products.
Valeant Pharmaceuticals International is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics.