FDA — authorised 13 March 2007
- Application: NDA022059
- Marketing authorisation holder: NOVARTIS
- Local brand name: TYKERB
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Tykerb in United States
FDA authorised Tykerb on 13 March 2007
Marketing authorisations
FDA
- Status: approved
Tykerb in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Tykerb approved in United States?
Yes. FDA authorised it on 13 March 2007; FDA has authorised it.
Who is the marketing authorisation holder for Tykerb in United States?
NOVARTIS holds the US marketing authorisation.