Bylvay
Bylvay ingredients
| Active ingredient | Strength |
|---|---|
| Odevixibat | 200 ug/1, 1200 ug/1, 400 ug/1, 600 ug/1 |
What Bylvay is used for
The FDA lists the approved uses on the official label (below). In the EU, odevixibat is approved as Bylvay for:
Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Bylvay
- Generic name
- Odevixibat
- Made by
- Ipsen Biopharmaceuticals, Inc.
- Forms
- Capsule, Capsule, Coated Pellets
- Given
- Oral
- Drug class
- Ileal Bile Acid Transporter Inhibitor
- FDA approval
- New drug application (NDA) NDA215498
- On the US market since
- 2024
Official information
- Bylvay prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Odevixibat)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Bylvay?
Bylvay (Odevixibat) is a specialist medicine made by Ipsen Biopharmaceuticals, Inc., approved by the US FDA.
What are the ingredients of Bylvay?
Bylvay contains Odevixibat (200 ug/1, 1200 ug/1, 400 ug/1, 600 ug/1).
Is Bylvay approved in Europe?
The same active substance is approved in the EU as Bylvay.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA