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Bausch’s Duobrii Promos Censured For Excluding Risk Info, Making Misleading Superiority Claims

 
• By Brenda Sandburg

Bausch gets an untitled letter from the US FDA criticizing a video and webpage promoting its psoriasis lotion. The agency also objects to superiority efficacy claims based on post hoc analyses of a single phase II trial after expressing similar concerns to the company two years ago.

Psoriasis
US FDA objects to Bausch's promotions for its psoriasis lotion Duobrii. • Source: Alamy

The US Food and Drug Administration’s Office of Prescription Drug Promotion rebuked Bausch Health Companies Inc. for promotions of its psoriasis lotion Duobrii (halobetasol propionate/tazarotene) that exclude risk information and suggest the drug is clinically superior to other treatments.

In a 31 March untitled letter, OPDP objected to a direct-to-consumer video that appeared on Lifetime TV’s The Balancing Act and a webpage about Duobrii targeted to healthcare professionals

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