FDA — authorised 20 July 2021
- Marketing authorisation holder: ALBIREO PHARMA INC
- Status: approved
🇺🇸 Bylvay in United States
FDA authorised Bylvay on 20 July 2021
Marketing authorisations
FDA — authorised 20 March 2025
- Application: NDA215498
- Marketing authorisation holder: IPSEN
- Indication: Labeling
- Status: approved
The FDA approved Bylvay, developed by IPSEN, for the treatment of labeling. This approval was granted through a standard expedited pathway. Bylvay is the local brand name for the drug.
Bylvay in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Bylvay approved in United States?
Yes. FDA authorised it on 20 July 2021; FDA authorised it on 20 March 2025.
Who is the marketing authorisation holder for Bylvay in United States?
ALBIREO PHARMA INC holds the US marketing authorisation.