FDA — authorised 11 January 2000
- Marketing authorisation holder: DAIICHI SANKYO
- Status: approved
🇺🇸 Evoxac in United States
FDA authorised Evoxac on 11 January 2000
Marketing authorisations
FDA — authorised 31 January 2001
- Application: NDA020989
- Marketing authorisation holder: COSETTE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 8 July 2013
- Application: ANDA091591
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 6 April 2023
- Application: ANDA216682
- Marketing authorisation holder: RUBICON RESEARCH
- Status: approved
FDA — authorised 18 April 2023
- Application: ANDA215056
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 24 July 2025
- Application: ANDA203775
- Marketing authorisation holder: RISING
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved Evoxac, manufactured by RISING, on 2025-07-24. This approval was granted under the standard expedited pathway. The approved indication is for manufacturing (CMC), which involves the control of manufacturing processes and facilities to ensure the quality of the drug product.
Evoxac in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Evoxac approved in United States?
Yes. FDA authorised it on 11 January 2000; FDA authorised it on 31 January 2001; FDA authorised it on 8 July 2013.
Who is the marketing authorisation holder for Evoxac in United States?
DAIICHI SANKYO holds the US marketing authorisation.