FDA — authorised 14 December 2012
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Signifor in United States
FDA authorised Signifor on 14 December 2012
Marketing authorisations
FDA — authorised 14 December 2012
- Application: NDA200677
- Marketing authorisation holder: RECORDATI RARE
- Local brand name: SIGNIFOR
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 9 March 2018
- Application: NDA203255
- Marketing authorisation holder: RECORDATI RARE
- Indication: Labeling
- Status: approved
Signifor 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 Signifor approved in United States?
Yes. FDA authorised it on 14 December 2012; FDA authorised it on 14 December 2012; FDA authorised it on 9 March 2018.
Who is the marketing authorisation holder for Signifor in United States?
NOVARTIS holds the US marketing authorisation.