FDA — authorised 23 December 1994
- Marketing authorisation holder: PIERRE FABRE
- Status: approved
🇺🇸 Navelbine in United States
FDA authorised Navelbine on 23 December 1994
Marketing authorisations
FDA — authorised 23 December 1994
- Application: NDA020388
- Marketing authorisation holder: PIERRE FABRE
- Local brand name: NAVELBINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 July 2020
- Application: ANDA078011
- Marketing authorisation holder: ACTAVIS TOTOWA
- Indication: Labeling
- Status: approved
FDA — authorised 27 July 2020
- Application: ANDA091106
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- Indication: Labeling
- Status: approved
Navelbine 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 Navelbine approved in United States?
Yes. FDA authorised it on 23 December 1994; FDA authorised it on 23 December 1994; FDA authorised it on 27 July 2020.
Who is the marketing authorisation holder for Navelbine in United States?
PIERRE FABRE holds the US marketing authorisation.