FDA — authorised 23 December 1987
- Status: approved
🇺🇸 Novantrone in United States
FDA authorised Novantrone on 23 December 1987
Marketing authorisations
FDA — authorised 23 December 1987
- Application: NDA019297
- Marketing authorisation holder: EMD SERONO
- Local brand name: NOVANTRONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 October 2000
- Application: NDA021120
- Marketing authorisation holder: SERONO INC
- Local brand name: NOVANTRONE
- Indication: INJECTABLE — INJECTION
- Status: approved
Novantrone 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 Novantrone approved in United States?
Yes. FDA authorised it on 23 December 1987; FDA authorised it on 23 December 1987; FDA authorised it on 13 October 2000.
Who is the marketing authorisation holder for Novantrone in United States?
Marketing authorisation holder not available in our data.