FDA — authorised 17 March 2015
- Marketing authorisation holder: RTRX
- Status: approved
🇺🇸 Cholbam in United States
FDA authorised Cholbam on 17 March 2015
Marketing authorisations
FDA — authorised 17 March 2015
- Application: NDA205750
- Marketing authorisation holder: MIRUM
- Indication: Type 1 - New Molecular Entity
- Status: approved
Cholbam in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Cholbam approved in United States?
Yes. FDA authorised it on 17 March 2015; FDA authorised it on 17 March 2015.
Who is the marketing authorisation holder for Cholbam in United States?
RTRX holds the US marketing authorisation.