FDA — authorised 15 September 1999
- Marketing authorisation holder: PFIZER INC
- Status: approved
🇺🇸 Ellence in United States
FDA authorised Ellence on 15 September 1999
Marketing authorisations
FDA — authorised 25 November 2024
- Application: NDA050778
- Marketing authorisation holder: PFIZER INC
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved Ellence, manufactured by Pfizer Inc, for manufacturing (CMC) purposes. This approval was granted through a standard pathway. The application number for this approval is NDA050778.
Ellence in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Ellence approved in United States?
Yes. FDA authorised it on 15 September 1999; FDA authorised it on 25 November 2024.
Who is the marketing authorisation holder for Ellence in United States?
PFIZER INC holds the US marketing authorisation.