FDA Accepts NDA for Plaque Psoriasis Treatment Jemdel
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Jemdel (halobetasol propionate 0.01%; Ortho Dermatologics) (IDP-122) lotion, an investigational treatment for plaque psoriasis.
Jemdel, if approved, will be the first high-potency topical steroid for plaque psoriasis with dosing for as long as 8 weeks. The most common adverse event in clinical trials of Jemdel was upper respiratory tract infection.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of October 5, 2018.
“If approved, we believe Jemdel will be an important option for patients with plaque psoriasis,” said Joseph C. Papa, chairman and CEO, Valeant. Ortho Dermatologics is a division of Valeant Pharmaceuticals.
For more information visit Ortho-Dermatologics.com.