From the Ashes of Scandal, Bausch Health Moves Ahead With Psoriasis Approval

MARK TERRY | April 26, 2019

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Bausch Health, formerly known as Valeant Pharmaceuticals International, announced that the U.S. Food and Drug Administration (FDA) had approved its Duobrii (halobetasol propionate and tazoretene) Lotion for plaque psoriasis. The drug, developed by a Bausch division, Ortho Dermatologics, was rejected by the agency in June 2018. Although few details were released, Bausch’s chairman and chief executive officer, Joseph Papa, stated at the time, “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. We are working to resolve this matter expeditiously and have already requested a meeting with the FDA.”

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Spotlight

Kent Pharmaceuticals

Kent Pharmaceuticals is one of the leading pharmaceutical companies in the UK with 29 years of expertise in supplying quality products and services to the primary and secondary care sectors. From generics, OTCs, own label, overlabelling or manufacturing, we tailor our offering to our customers.

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