FDA — authorised 24 July 2015
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Status: approved
🇺🇸 Daklinza in United States
FDA authorised Daklinza on 24 July 2015
Marketing authorisations
FDA — authorised 24 July 2015
- Application: NDA206843
- Marketing authorisation holder: BRISTOL-MYERS SQUIBB
- Local brand name: DAKLINZA
- Indication: TABLET — ORAL
- Status: approved
Daklinza 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 Daklinza approved in United States?
Yes. FDA authorised it on 24 July 2015; FDA authorised it on 24 July 2015.
Who is the marketing authorisation holder for Daklinza in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.