Home / Drug News / FDA Accepts Ortho Dermatologic’s NDA for Novel Plaque Psoriasis Treatment, IDP-118

FDA Accepts Ortho Dermatologic’s NDA for Novel Plaque Psoriasis Treatment, IDP-118

The US Food and Drug Administration has accepted Ortho Dermatologic’s New Drug Application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion, an investigational topical treatment for plaque psoriasis. The PDUFA action date is June 18, 2018.

If approved, IDP-118 will be the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, allowing for a potentially expanded duration of use. The most common adverse events were contact dermatitis (7.4 percent ) and application site pain (2.6 percent).

Ortho Dermatologics is a division of Valeant Pharmaceuticals International, Inc.

About Dr. J. Kim

Dr Kim developed (and is continuing to develop) dermatology research news as we way from dermatologists to stay on top of the latest advances in the field of dermatology.

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