Ortho Dermatologics said it received a complete response letter from FDA to an NDA for Duobrii (IDP-118) to treat plaque psoriasis. Ortho parent Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) slid $3.32 (12%) to $23.54 on NYSE and C$4.38 (12%) to C$31.09 in Toronto on Monday.
According to Valeant, FDA had questions related to pharmacokinetic data.
The company said it requested a meeting with FDA. Valeant spokesperson Lainie Keller told BioCentury the company plans to resubmit the NDA but is not disclosing a timeline.
Duobrii is a topical formulation of halobetasol propionate, a corticosteroid, and tazarotene, a retinoid prodrug.