Ortho Dermatologics files JEMDEL NDA with US FDA for JEMDE for plaque psoriasis
15 February 2018 -

Ortho Dermatologics said on Wednesday that it has successfully filed its New Drug Application for JEMDEL (halobetasol propionate 0.01%) (IDP-122) lotion with the US Food and Drug Administration (FDA) for the treatment of plaque psoriasis.

In conjunction with the filing of JEMDEL with the US FDA, the company has been assigned a PDUFA action date of 5 October 2018.

Upon approval, 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, added the company.

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.

Ortho Dermatologics is a division of Valeant Pharmaceuticals International Inc (NYSE:VRX)(TSX:VRX), which develops, manufactures and markets a broad range of pharmaceutical products primarily in dermatology, gastrointestinal disorders, eye health, neurology and branded generics.