FDA — authorised 30 April 2009
- Application: BLA020725
- Marketing authorisation holder: ABBVIE
- Local brand name: CREON
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 CREON in United States
FDA authorised CREON on 30 April 2009
Marketing authorisations
FDA — authorised 12 April 2010
- Application: BLA022523
- Marketing authorisation holder: VIVUS INC
- Indication: Type 7 - Drug Already Marketed without Approved NDA
- Status: approved
FDA — authorised 20 March 2020
- Application: BLA022210
- Marketing authorisation holder: EURAND PHARMA LTD
- Indication: Labeling
- Status: approved
CREON in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is CREON approved in United States?
Yes. FDA authorised it on 30 April 2009; FDA authorised it on 12 April 2010; FDA authorised it on 20 March 2020.
Who is the marketing authorisation holder for CREON in United States?
ABBVIE holds the US marketing authorisation.