FDA — authorised 26 October 2012
- Application: NDA203585
- Marketing authorisation holder: TEVA PHARMS INTL
- Local brand name: SYNRIBO
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
🇺🇸 Omacetaxine in United States
FDA authorised Omacetaxine on 26 October 2012
Marketing authorisation
Other Oncology approved in United States
Frequently asked questions
Is Omacetaxine approved in United States?
Yes. FDA authorised it on 26 October 2012.
Who is the marketing authorisation holder for Omacetaxine in United States?
TEVA PHARMS INTL holds the US marketing authorisation.