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# FDA Tentatively Approves Ortho’s Psoriasis Lotion
- URL: https://www.fdaweb.com/fda-tentatively-approves-orthos-psoriasis-lotion/
- Published: 2018-10-08T12:00:00.000Z
- Updated: 2026-09-15T00:36:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142536

FDA has tentatively approved an Ortho Dermatologics NDA for Bryhali (halobetasol propionate) lotion for the topical treatment of plaque psoriasis in adult patients. In clinical trials, the lotion demonstrated significant treatment success over a vehicle as early as week two, according to the company. “Its safety has been established in clinical trials with dosing for up to eight weeks with no increase in epidermal atrophy,” it says. Final FDA approval is pending the expiration of Sun Pharmaceutical’s Ultravate’s exclusivity, which will occur next month.