FDA — authorised 14 May 2001
- Application: ANDA065031
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Blenoxane in United States
FDA authorised Blenoxane on 14 May 2001
Marketing authorisations
FDA — authorised 25 April 2011
- Application: ANDA065042
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 8 November 2011
- Application: ANDA065185
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 20 April 2018
- Application: ANDA205030
- Marketing authorisation holder: MEITHEAL
- Status: approved
Blenoxane 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 Blenoxane approved in United States?
Yes. FDA authorised it on 14 May 2001; FDA authorised it on 25 April 2011; FDA authorised it on 8 November 2011.
Who is the marketing authorisation holder for Blenoxane in United States?
HOSPIRA holds the US marketing authorisation.