FDA — authorised 14 April 2023
- Application: NDA216264
- Marketing authorisation holder: PROVEPHARM SAS
- Indication: Labeling
- Status: approved
🇺🇸 Bludigo in United States
FDA authorised Bludigo on 14 April 2023
Marketing authorisations
FDA
- Marketing authorisation holder: PROVEPHARM SAS
- Status: approved
Bludigo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Nephrology approved in United States
Frequently asked questions
Is Bludigo approved in United States?
Yes. FDA authorised it on 14 April 2023; FDA has authorised it.
Who is the marketing authorisation holder for Bludigo in United States?
PROVEPHARM SAS holds the US marketing authorisation.