FDA accepts new drug application of Jemdel for psoriasis

[Fred]

The U.S. Food and Drug Administration (FDA) has accepted Jemdel as a new drug application to treat psoriasis.  

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Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application for JEMDEL™1 (halobetasol propionate 0.01%) (IDP-122) lotion with a PDUFA action date of Oct. 5, 2018. 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.

Source: valeant.com