FDA accepts Ortho Dermatologics JEMDEL for Plaque Psoriasis Treatment

Division of Valeant Pharmaceuticals International, Inc., Ortho Dermatologics asserted that the U.S Food and Drug Administration accepted the New Drug Application for JEMDEL  (halobetasol propionate 0.01%) (IDP-122) lotion with a PDUFA action date of Oct. 5, 2018.

Psoriasis is a chronic, painful and frequently life-altering immune-mediated inflammatory skin disease associated with serious comorbidities and substantial impairment of physical and psychological quality of life. More than 75% of patients with moderate-to-severe plaque psoriasis experience significant itching, and greater than 55% report moderate or worse levels of pain

Joseph C. Papa, chairman and CEO, Valeant said ” The impact of psoriasis can be devastating for the millions of patients who live with the pain and stigma of this lifelong chronic condition.”