Ortho Dermatologics – now a Valeant company – has announced receipt of a complete response letter (CRL) from the US Food and Drug Administration (FDA), rejecting prescription skin lotion Duobrii (halobetasol propionate and tazarotene).
"The CRL did not specify any deficiencies related to the clinical efficacy or safety of Duobrii and no issues with CMC [chemistry, manufacturing, and controls] processes. The CRL only noted questions regarding pharmacokinetic data," said Valeant CEO Joseph C. Papa in a statement.
"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," he added.
Last month, Valeant announced plans to rebrand as Bausch Health Companies. From July 2018, the firm will officially discard the ‘Valeant’ name – which has been linked to a troubled past of congressional investigations, lawsuits, and arrests.
“I’m excited about this development because it signals we’ve reached an important point in the turnaround process. The steps we have taken are yielding concrete results and we’re beginning to turn the page away from legacy issues that have been headwinds over the past few years,” Papa told investors last month.