Stiefel/GSK Receives FDA Approval of Sorilux Foam, 0.005%

The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Sorilux (calcipotriene) Foam, 0.005% from Stiefel/GSK. The sNDA expands the indication for Sorilux Foam to include the topical treatment of plaque psoriasis of the scalp in patients aged 18 years and older. The approval was based on a multi-center, randomized, double-blind, vehicle-controlled pivotal Phase 3b study of patients with moderate scalp and body psoriasis. The most common side effects of Sorilux Foam were redness and pain of the treated skin areas.