Sorilux Receives Expanded Indication
May 22, 2019 – The U.S. FDA has approved an expanded indication for Sorilux® (calcipotriene) foam 0.005%, manufactured by Mayne Pharma, to treat plaque psoriasis of the scalp and body in patients who are at least 12 years of age.
First approved in 2010 to treat adults, Sorilux is a synthetic vitamin D analog believed to decrease the production of psoriasis cells. Recommended dosing is a thin layer applied twice daily to affected areas. Contact with the face and eyes should be avoided. The foam dosage form is free of greasiness or stickiness associated with other types of topical products.
Expanded approval for Sorilux was granted based on the results of an open label study in patients ages 12 to 17 years who have psoriasis.