FDA — authorised 3 July 2014
- Application: NDA206256
- Marketing authorisation holder: ACROTECH BIOPHARMA
- Local brand name: BELEODAQ
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Beleodaq in United States
FDA authorised Beleodaq on 3 July 2014
Marketing authorisation
Beleodaq 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 Beleodaq approved in United States?
Yes. FDA authorised it on 3 July 2014.
Who is the marketing authorisation holder for Beleodaq in United States?
ACROTECH BIOPHARMA holds the US marketing authorisation.