FDA — authorised 27 November 2009
- Marketing authorisation holder: DYAX CORP.
- Status: approved
🇺🇸 Kalbitor in United States
FDA authorised Kalbitor on 27 November 2009
Marketing authorisations
FDA — authorised 1 December 2009
- Application: BLA125277
- Marketing authorisation holder: DYAX CORP.
- Local brand name: KALBITOR
- Indication: INJECTABLE — INJECTION
- Status: approved
Kalbitor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Kalbitor approved in United States?
Yes. FDA authorised it on 27 November 2009; FDA authorised it on 1 December 2009.
Who is the marketing authorisation holder for Kalbitor in United States?
DYAX CORP. holds the US marketing authorisation.