Treats molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD). NDA 213687, held by Ultragenyx Pharm Inc. Triheptanoin.
As of Nov 14, 2026, NDA 213687 (Dojolvi), held by Ultragenyx Pharm Inc, was first approved by FDA on Jun 30, 2020, with 1 approved supplement and 0 published complete response letters.
DOJOLVI is indicated as a source of calories and fatty acids for the treatment of adult and pediatric patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 2020 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dojolvi100% w/w · liquid;oral | Triheptanoin | RxReference drug |
| Oct 30, 2023 | Supplement 3Labeling · Standard review | Approved | |
| Jun 30, 2020 | 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
