What is the generic name?

ODEVIXIBAT

What is the Trade Name for ODEVIXIBAT?

BYLVAY

What are the Indications for ODEVIXIBAT?

• 1 INDICATIONS AND USAGE BYLVAY is indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). ( 1 ) Limitation of Use: BYLVAY may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3). Limitations of Use BYLVAY may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3).

References: https://open.fda.gov/