The company plans to launch the lotion in November after receiving final approval from the FDA, pending expiration of exclusivity for a related product
Bausch Health Cos, formerly known as Valeant Pharmaceuticals, said recently that it received tentative US approval to market its plaque psoriasis lotion, Bryhali.
The FDA’s tentative approval comes after a similar treatment from the company failed to win clearance in June.
Bausch Health’s treatment was applied once daily for eight weeks in clinical trials and was generally well-tolerated with no increase in epidermal atrophy, the company said in a statement.
Bryhali is a steroid treatment for the chronic condition that causes dry, red skin lesions covered with silvery scales.
Topical steroids are the most frequently used treatment for psoriasis, but long-term use has been limited due to risks of adverse events such as epidermal atrophy.