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FDA NDA · NDA215498

BYLVAY

odevixibat

Sponsor: IPSEN

APPLICATION
NDA215498
TYPE
NDA
ORIGINAL APPROVAL
2021-07-20
LATEST ACTION
2025-12-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE, CAPSULE, PELLETS
MARKETING STATUS
Prescription

Products

BYLVAY · ReferencePrescription
ODEVIXIBAT 1.2MG · CAPSULE · ORAL
BYLVAY · ReferencePrescription
ODEVIXIBAT 0.4MG · CAPSULE · ORAL
BYLVAY · ReferencePrescription
ODEVIXIBAT 0.6MG · CAPSULE, PELLETS · ORAL
BYLVAY · ReferencePrescription
ODEVIXIBAT 0.2MG · CAPSULE, PELLETS · ORAL

Approval history

2025-12-19Efficacy · Supplement 5 · standard — Label ↗AP
2025-03-20Labeling · Supplement 6 · standard — Label ↗AP
2023-06-13Efficacy · Supplement 3 · priority — Letter ↗AP
2023-05-08Labeling · Supplement 4 · standard — Label ↗AP
2022-10-21Labeling · Supplement 2 · standard — Letter ↗AP
2021-07-20Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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