Treats locally advanced basal cell carcinoma (BCC). NDA 205266, held by Sun Pharm. Sonidegib Phosphate.
As of Nov 15, 2026, NDA 205266 (Odomzo), held by Sun Pharm, was first approved by FDA on Jul 24, 2015, with 5 approved supplements and 0 published complete response letters.
ODOMZO (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
| Sep 18, 2017 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 2015 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| OdomzoEQ 200MG BASE · capsule;oral | Sonidegib Phosphate | RxReference drug |
| Aug 22, 2023 | Supplement 9Labeling · Standard review | Approved | |
| May 13, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Sep 18, 2017 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| May 12, 2016 | Supplement 2Labeling · Standard review | Approved | |
| Feb 17, 2016 | Supplement 3Labeling · Standard review | Approved | |
| Jul 24, 2015 | Original applicationNew molecular entity · 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
