FDA — authorised 28 April 2017
- Marketing authorisation holder: NOVARTIS PHARMS CORP
- Status: approved
🇺🇸 Rydapt in United States
FDA authorised Rydapt on 28 April 2017
Marketing authorisations
FDA — authorised 28 April 2017
- Application: NDA207997
- Marketing authorisation holder: NOVARTIS
- Local brand name: RYDAPT
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 April 2024
- Application: ANDA216076
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: MIDOSTAURIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 May 2024
- Application: ANDA216015
- Marketing authorisation holder: LUPIN
- Local brand name: MIDOSTAURIN
- Indication: CAPSULE — ORAL
- Status: approved
Rydapt 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 Rydapt approved in United States?
Yes. FDA authorised it on 28 April 2017; FDA authorised it on 28 April 2017; FDA authorised it on 29 April 2024.
Who is the marketing authorisation holder for Rydapt in United States?
NOVARTIS PHARMS CORP holds the US marketing authorisation.