Linerixibat
Linerixibat is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Lynavoy. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- Linerixibat
- Brand Names
- Lynavoy
- Application Number
- NDA220295
- Sponsor
- Intercept Pharmaceuticals Inc
- NDC Codes
- 3
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- LINERIXIBAT
Indications and Usage
1 INDICATIONS AND USAGE LYNAVOY is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy) [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ] . LYNAVOY is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. ( 1 ) Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy). ( 1 )