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

Thursday, November 02, 2017 | FDA Approval/Clearance , Psoriasis , Product Launches and Updates , Valeant NJ

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.

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