Showing posts with label Novel Plaque Psoriasis Treatment. Show all posts
Showing posts with label Novel Plaque Psoriasis Treatment. Show all posts

Thursday, January 11, 2018

Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-118, Novel Plaque Psoriasis Treatment

Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX), today announced that the U.S. Food and Drug Administration (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.
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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%)...