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.”