FDA accepts NDA for IDP 118, a topical treatment for plaque psoriasis.- Ortho Dermatologics/Valeant.
Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. announced that the FDA has accepted the 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%) and application site pain. (2.6%).
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