Treats human smallpox disease. NDA 208627, held by Siga Technologies. Tecovirimat.
As of Nov 13, 2026, NDA 208627 (Tpoxx), held by Siga Technologies, was first approved by FDA on Jul 13, 2018, with 3 approved supplements and 0 published complete response letters.
TPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. Limitations of Use: The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models. 1.1 Treatment of Human Smallpox Disease
| May 18, 2022 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Nov 23, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jul 13, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tpoxx200MG · capsule;oral | Tecovirimat | RxReference drug |
| Jun 3, 2024 | Supplement 8Labeling · Standard review | Approved | |
| May 18, 2022 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Nov 23, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jul 13, 2018 | 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
