Ortho Dermatologics Says FDA Issues CRL For DUOBRII Lotion

(RTTNews) - Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (VRX, VRX.TO), said that it has received a Complete Response Letter or CRL from the U.S. Food and Drug Administration regarding the company's New Drug Application or NDA for DUOBRII 1 (halobetasol propionate and tazarotene) or IDP-118 lotion in the treatment of plaque psoriasis.

"The CRL did not specify any deficiencies related to the clinical efficacy or safety of DUOBRII and no issues with CMC* processes. The CRL only noted questions regarding pharmacokinetic data," said Joseph Papa, chairman and CEO, Valeant.

"We are working to resolve this matter expeditiously and have already requested a meeting with the FDA. We hope to bring forward this important new treatment option for those who suffer from plaque psoriasis as quickly as possible," said Papa.