FDA — authorised 30 November 2015
- Application: BLA761035
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 Huluc63 in United States
FDA authorised Huluc63 on 30 November 2015
Marketing authorisation
Huluc63 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 Huluc63 approved in United States?
Yes. FDA authorised it on 30 November 2015.
Who is the marketing authorisation holder for Huluc63 in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.