FDA — authorised 29 October 2021
- Application: NDA215358
- Marketing authorisation holder: NOVARTIS
- Local brand name: SCEMBLIX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Scemblix in United States
FDA authorised Scemblix on 29 October 2021
Marketing authorisations
FDA
- Status: approved
Scemblix 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 Scemblix approved in United States?
Yes. FDA authorised it on 29 October 2021; FDA has authorised it.
Who is the marketing authorisation holder for Scemblix in United States?
NOVARTIS holds the US marketing authorisation.