Treats plaque psoriasis of the scalp and body. NDA 22563, held by Mayne Pharma. Calcipotriene.
As of Nov 15, 2026, NDA 22563 (Sorilux), held by Mayne Pharma, was first approved by FDA on Oct 6, 2010, with 6 approved supplements and 0 published complete response letters.
Calcipotriene foam is indicated for the topical treatment of plaque psoriasis of the scalp and body in adults and pediatric patients 4 years of age and older.
| Nov 5, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| May 6, 2019 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Sep 27, 2012 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2010 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sorilux0.005% · aerosol, foam;topical | Calcipotriene | RxReference drug |
| Nov 5, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Nov 5, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| May 6, 2019 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jul 10, 2015 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Sep 27, 2012 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Apr 21, 2011 | Supplement 1Labeling | Approved | |
| Oct 6, 2010 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
