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Bausch Health's plaque psoriasis lotion gets tentative US FDA nod

Bausch Health Cos. Inc. and its dermatology unit, Ortho Dermatologics, said the U.S. Food and Drug Administration tentatively approved Bryhali, a lotion intended to treat plaque psoriasis in adults.

Plaque psoriasis is the most common form of psoriasis, in which the skin is red and covered with silvery scales or patches. It is usually treated with steroids, which can cause adverse effects after prolonged use, such as epidermal atrophy, the thinning or depression of skin due to the reduction of underlying tissue.

The FDA's approval is backed by the results of clinical studies in which Bryhali, a highly potent steroid also known as halobetasol propionate, achieved treatment success with no increase in epidermal atrophy despite being administered for up to eight weeks. Normally, the use of steroids in plaque psoriasis patients is limited to two to four weeks.

Canada-based Bausch expects to receive the lotion's final approval in early November, following the expiration of exclusivity for a related product.