
The FDA has charged Bausch Health with making false or misleading claims about its topical plaque psoriasis cream Duobrii.
A fixed combination of tazarotene and halobetasol propionate lotion, Duobrii was approved by the FDA to treat plaque psoriasis in 2019.
In a March 31, 2022, letter to the company, the FDA’s Office of Prescription Drug Promotion (OPDP) called out a video, which aired on network television, for failing to include information regarding potential embryofetal risk or the risk of photosensitivity or sunburn.
“By omitting serious risks associated with Duobrii and