FDA — authorised 4 October 2016
- Application: NDA201292
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Labeling
- Status: approved
🇺🇸 Gilotrif in United States
FDA authorised Gilotrif on 4 October 2016
Marketing authorisation
Gilotrif 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 Gilotrif approved in United States?
Yes. FDA authorised it on 4 October 2016.
Who is the marketing authorisation holder for Gilotrif in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.