FDA — authorised 10 March 2016
- Application: NDA207155
- Marketing authorisation holder: ACROTECH BIOPHARMA
- Local brand name: EVOMELA
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Evomela in United States
FDA authorised Evomela on 10 March 2016
Marketing authorisations
FDA — authorised 22 March 2017
- Application: ANDA207809
- Marketing authorisation holder: ALVOGEN
- Local brand name: MELPHALAN
- Indication: TABLET — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Evomela approved in United States?
Yes. FDA authorised it on 10 March 2016; FDA authorised it on 22 March 2017.
Who is the marketing authorisation holder for Evomela in United States?
ACROTECH BIOPHARMA holds the US marketing authorisation.