FDA — authorised 23 November 2021
- Application: NDA208627
- Marketing authorisation holder: SIGA TECHNOLOGIES
- Indication: Efficacy
- Status: approved
🇺🇸 TECOVIRIMAT MONOHYDRATE in United States
FDA authorised TECOVIRIMAT MONOHYDRATE on 23 November 2021 · 3 US adverse-event reports
Marketing authorisations
FDA — authorised 18 May 2022
- Application: NDA214518
- Marketing authorisation holder: SIGA TECHNOLOGIES
- Indication: Type 3 - New Dosage Form
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 3
Most-reported reactions
- Hepatic Cytolysis — 3 reports (100%)
TECOVIRIMAT MONOHYDRATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is TECOVIRIMAT MONOHYDRATE approved in United States?
Yes. FDA authorised it on 23 November 2021; FDA authorised it on 18 May 2022.
Who is the marketing authorisation holder for TECOVIRIMAT MONOHYDRATE in United States?
SIGA TECHNOLOGIES holds the US marketing authorisation.