Valeant dealt 'a major setback' as psoriasis dual-drug lotion Duobrii fails to impress FDA

Besides getting a new name, troubled Valeant is also in desperate need of some regulatory success to rebuild its image. But it’s not going to get it from a key plaque psoriasis combo drug Doubrii—at least not soon. The FDA has just rejected Doubrii, one of the seven products that Valeant hoped would collectively generate $1 billion of annual sales over the next five years, Valeant’s Ortho Dermatologics division announced Monday. In a statement, Chairman and CEO Joseph Papa said the complete response letter “did not specify any deficiencies related to the clinical efficacy or safety of Duobrii and no issues with CMC processes.” Instead it “only noted questions regarding pharmacokinetic data.” He added that the company has already requested a meeting with the agency to resolve the concern “expeditiously.”