General MedicationsORALStandard
BYLVAY
ODEVIXIBAT
Standard Dose
1.2MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BYLVAY is listed in Drugs@FDA under application 215498 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ODEVIXIBAT Form and strength CAPSULE;ORAL - 1.2MG Sponsor IPSEN Submission history Latest submission status date: 2025-12-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview BYLVAY is listed in Drugs@FDA under application 215498 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ODEVIXIBAT Form and strength CAPSULE;ORAL - 1.2MG Sponsor IPSEN Submission history Latest submission status date: 2025-12-19 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.