BLA 103767, held by Eisai Inc. Denileukin Diftitox.
As of Nov 13, 2026, BLA 103767 (Ontak), held by Eisai Inc, was first approved by FDA on Feb 5, 1999, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2008 | Supplement 5094Efficacy (new indication or use) · Priority review | Approved | |
| Feb 5, 1999 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ontak150UG/ML · vial | Denileukin Diftitox | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 10, 2020 | Supplement 5144Labeling · Standard review | Approved | |
| Feb 15, 2019 | Supplement 5143Labeling · Standard review | Approved | |
| Aug 30, 2011 | Supplement 5119 | Approved | |
| Mar 5, 2010 | Supplement 5118Labeling · Standard review | Approved | None posted |
| Oct 15, 2008 | Supplement 5094Efficacy (new indication or use) · Priority review | Approved | |
| Feb 5, 1999 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
