FDA — authorised 13 March 2007
- Marketing authorisation holder: NOVARTIS PHARMS CORP
- Status: approved
🇺🇸 Tykerb in United States
FDA authorised Tykerb on 13 March 2007
Marketing authorisations
FDA — authorised 20 August 2007
- Application: NDA022059
- Marketing authorisation holder: NOVARTIS
- Indication: Labeling
- Status: approved
FDA — authorised 29 September 2020
- Application: ANDA203007
- Marketing authorisation holder: NATCO PHARMA LTD
- Status: approved
FDA — authorised 16 August 2024
- Application: ANDA217968
- Marketing authorisation holder: TEVA PHARMS USA INC
- 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 Oncology approved in United States
Frequently asked questions
Is Tykerb approved in United States?
Yes. FDA authorised it on 13 March 2007; FDA authorised it on 20 August 2007; FDA authorised it on 29 September 2020.
Who is the marketing authorisation holder for Tykerb in United States?
NOVARTIS PHARMS CORP holds the US marketing authorisation.