Treats the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human…. NDA 214429, held by Sanofi. Fexinidazole.
As of Nov 14, 2026, NDA 214429 (Fexinidazole), held by Sanofi, was first approved by FDA on Jul 16, 2021, with 3 approved supplements and 1 published complete response letter.
Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. Fexinidazole Tablets is a nitroimidazole antimicrobial, indicated for the treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 2021 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Nov 12, 2020 | Fexinidazole | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fexinidazole600MG · tablet;oral | Fexinidazole | RxReference drug |
| Sep 20, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Sep 20, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Dec 15, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Jul 16, 2021 | 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
