Treats unresectable or metastatic melanoma with BRAF V600E mutation. NDA 202429, held by Hoffmann La Roche. Vemurafenib.
As of Nov 15, 2026, NDA 202429 (Zelboraf), held by Hoffmann La Roche, was first approved by FDA on Aug 17, 2011, with 15 approved supplements and 0 published complete response letters.
ZELBORAF is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1, 2.1 ) ZELBORAF is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. ( 1.2, 2.1 ) Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1, 5.2 ) 1.1 Unresectable or Metastatic Melanoma
| Nov 6, 2017 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Sep 13, 2017 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Aug 31, 2016 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Mar 19, 2014 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Aug 17, 2011 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zelboraf240MG · tablet;oral | Vemurafenib | RxReference drug |
| Aug 20, 2026 | Supplement 23Labeling · Standard review | Approved | |
| May 18, 2020 | Supplement 19Labeling · Standard review | Approved | |
| Nov 6, 2017 | Supplement 16Efficacy (new indication or use) · Priority review | Approved | |
| Sep 13, 2017 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Sep 13, 2017 | Supplement 15Labeling · Standard review | Approved | |
| Apr 17, 2017 | Supplement 12Labeling · Standard review | Approved | |
| Aug 31, 2016 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| May 9, 2016 | Supplement 10Labeling · Standard review | Approved | |
| Aug 11, 2015 | Supplement 8Labeling · Standard review | Approved | |
| Nov 25, 2014 | Supplement 6Labeling · Standard review | Approved | |
| Sep 23, 2014 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Mar 19, 2014 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 6, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Jul 3, 2013 | Supplement 2Labeling · Standard review | Approved | |
| Jul 3, 2013 | Supplement 3Labeling · Standard review | Approved | |
| Aug 17, 2011 | Original applicationNew molecular entity · Priority 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
