FDA — authorised 26 December 1990
- Application: NDA019926
- Marketing authorisation holder: EISAI INC
- Local brand name: HEXALEN
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Hexalen in United States
FDA authorised Hexalen on 26 December 1990
Marketing authorisations
FDA
- Status: approved
Hexalen 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 Hexalen approved in United States?
Yes. FDA authorised it on 26 December 1990; FDA has authorised it.
Who is the marketing authorisation holder for Hexalen in United States?
EISAI INC holds the US marketing authorisation.