Posted by Michael Wonder on 08 Oct 2018
Bausch Health's Bryhali (halobetasol propionate) 0.01% lotion receives tentative FDA approval for plaque psoriasis in adults
8 October 2018 - Company plans to launch Bryhali lotion in November 2018 upon final FDA approval.
Bausch Health and its dermatology business, Ortho Dermatologics today announced that the U.S. FDA has provided tentative approval of the new drug application for Bryhali (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients.
Bryhali lotion is a new potent to superpotent corticosteroid that contains 0.01% halobetasol propionate in a novel vehicle lotion. Its safety has been established in clinical trials with dosing for up to eight weeks with no increase in epidermal atrophy. The final FDA approval for Bryhali lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018.
