Treats human smallpox disease. NDA 214460, held by Emergent Biodefense. Brincidofovir.
As of Nov 13, 2026, NDA 214460 (Tembexa), held by Emergent Biodefense, was first approved by FDA on Jun 4, 2021, with 1 approved supplement and 0 published complete response letters.
TEMBEXA is an orthopoxvirus nucleotide analog DNA polymerase inhibitor and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. Limitations of Use:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 4, 2021 | Original applicationNew active ingredient · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tembexa10MG/ML · suspension;oral | Brincidofovir | RxReference drug |
| Aug 3, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Jun 4, 2021 | Original applicationNew active ingredient · 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
