FDA — authorised 4 November 2016
- Application: NDA208434
- Marketing authorisation holder: HOFFMANN-LA ROCHE
- Indication: Labeling
- Status: approved
🇺🇸 Alecensa in United States
FDA authorised Alecensa on 4 November 2016
Marketing authorisation
Alecensa 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 Alecensa approved in United States?
Yes. FDA authorised it on 4 November 2016.
Who is the marketing authorisation holder for Alecensa in United States?
HOFFMANN-LA ROCHE holds the US marketing authorisation.