FDA — authorised 13 March 2020
- Application: NDA208574
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: ROMIDEPSIN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 depsipeptide in United States
FDA authorised depsipeptide on 13 March 2020
Marketing authorisations
FDA — authorised 12 October 2021
- Application: ANDA206254
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ROMIDEPSIN
- Indication: POWDER — INTRAVENOUS
- Status: approved
Other Other approved in United States
Frequently asked questions
Is depsipeptide approved in United States?
Yes. FDA authorised it on 13 March 2020; FDA authorised it on 12 October 2021.
Who is the marketing authorisation holder for depsipeptide in United States?
TEVA PHARMS USA INC holds the US marketing authorisation.