maralixibat chloride
maralixibat chloride is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand name including Livmarli. Available dosage forms: tablet, solution.
Drug Details
- Generic Name
- maralixibat chloride
- Brand Names
- Livmarli
- Application Number
- NDA219485
- Sponsor
- Mirum Pharmaceuticals Inc.
- NDC Codes
- 6
- Dosage Forms
- TABLET, SOLUTION
- Routes
- ORAL
- Active Ingredients
- MARALIXIBAT CHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE LIVMARLI is an ileal bile acid transporter (IBAT) inhibitor indicated for: • the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS). ( 1.1 ) • the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC). ( 1.2 ) o Limitations of Use: LIVMARLI is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of bile salt export pump (BSEP) protein. ( 14.2 ) 1.1 Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome LIVMARLI ® is indicated for the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS). 1.2 Treatment of Cholestatic Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis LIVMARLI is indicated for the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC). Limitations of Use: LIVMARLI is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of bile salt export pump (BSEP) protein [see Clinical Studies (14.2) ] .