FDA — authorised 15 November 2010
- Marketing authorisation holder: EISAI INC
- Status: approved
🇺🇸 Halaven in United States
FDA authorised Halaven on 15 November 2010
Marketing authorisations
FDA — authorised 15 November 2010
- Application: NDA201532
- Marketing authorisation holder: EISAI INC
- Local brand name: HALAVEN
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Halaven 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 Halaven approved in United States?
Yes. FDA authorised it on 15 November 2010; FDA authorised it on 15 November 2010.
Who is the marketing authorisation holder for Halaven in United States?
EISAI INC holds the US marketing authorisation.