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Valeant Draws Complete Response Letter
Drugs Regulatory Affairs
The FDA issued Valeant Pharmaceuticals a complete response letter for its plaque psoriasis lotion Duobrii (halobetasol propionate and tazarotene) questioning the product’s pharmacokinetic data.
The agency did not specify any deficiencies related to clinical efficacy or safety or issues with its chemistry, manufacturing and control processes, according to Valeant’s Chairman and CEO, Joseph C. Papa.
The company has spent much of 2018 embroiled in lawsuits. In March, former Valeant executives were found guilty of participating in a kickback scheme, and in January a group of investors sued the company for alleged price gouging they said cost them more than $80 billion.