Treats human smallpox disease. NDA 214518, held by Siga Technologies. Tecovirimat.
As of Nov 14, 2026, NDA 214518 (Tpoxx), held by Siga Technologies, was first approved by FDA on May 18, 2022, with 1 approved supplement 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
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 2022 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tpoxx200MG/20ML (10MG/ML) · solution;intravenous | Tecovirimat | RxReference drug |
| Jun 3, 2024 | Supplement 3Labeling · Standard review | Approved | |
| May 18, 2022 | Original applicationNew dosage form · 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
