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FDA Declines to Approve Valeant's Plaque Psoriasis Lotion

June 18, 2018

By Manas Mishra

(Reuters) - Valeant Pharmaceuticals International Inc's plaque psoriasis treatment Duobrii (halobetasol propionate and tazarotene) did not get approval from U.S. health regulators, a setback for the company which had high hopes for the lotion.

The U.S. Food and Drug Administration's letter to the company did not cite any deficiencies related to clinical safety or efficacy of the treatment, Duobrii, but highlighted questions regarding pharmacokinetic data, Valeant said.

Valeant did not elaborate further on the data that the FDA had questioned. Additional data, if required by the FDA, may take as much as six or more months to be generated, Wells Fargo analyst David Maris said in a note.

"We suspect that Duobrii is no longer a 2018 launch, as Valeant had previously guided, and may not even be a 2019 event," Maris added.

Chief Executive Officer Joseph Papa has worked for the past two years to regain investor confidence following a flurry of investigations into Valeant's accounting and pricing practices and has been building on the company's product portfolio. Valeant in May said it would change its name to Bausch Health Cos Inc, as it seeks to distance itself from a series of scandals and accounting issues under the its previous management.

Valeant has requested a meeting with the U.S. health agency as it worked towards Duobrii's approval, Chief Executive Officer Papa said on Monday. Duobrii sales could reach up to $175 million in 2022, according to Mizuho analyst Irina Koffler, who said the estimate was still achievable, provided Valeant could rapidly address the FDA's questions.

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