FDA — authorised 29 August 2017
- Application: NDA209570
- Marketing authorisation holder: CHEMO RESEARCH SL
- Local brand name: BENZNIDAZOLE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Benznidazole in United States
FDA authorised Benznidazole on 29 August 2017
Marketing authorisation
Benznidazole in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Benznidazole approved in United States?
Yes. FDA authorised it on 29 August 2017.
Who is the marketing authorisation holder for Benznidazole in United States?
CHEMO RESEARCH SL holds the US marketing authorisation.