FDA Accepts Ortho Dermatologics' NDA For Jemdel Plaque Psoriasis Treatment

The FDA has accepted the New Drug Application for Jemdel (halobetasol propionate 0.01%) (IDP-122) lotion from Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. If approved, Jemdel will be the first high-potency topical steroid treatment for plaque psoriasis with dosing for as long as eight weeks. In the clinical trials, the most common adverse event was upper respiratory tract infection. The PDUFA action date is Oct. 5, 2018.

"The impact of psoriasis can be devastating for the millions of patients who live with the pain and stigma of this lifelong chronic condition," says Joseph C. Papa, chairman and CEO, Valeant, in a release. "If approved, we believe Jemdel will be an important option for patients with plaque psoriasis."