entecavir

FDA Drug Profile — ENTECAVIR, BARACLUDE, Entecavir

Drug Details

Generic Name
entecavir
Brand Names
ENTECAVIR, BARACLUDE, Entecavir
Application Number
ANDA212201
Sponsor
Patheon, Inc.
NDC Codes
10
Dosage Forms
TABLET, FILM COATED, SOLUTION
Routes
ORAL
Active Ingredients
ENTECAVIR, ENTECAVIR ANHYDROUS

Indications and Usage

1 INDICATIONS AND USAGE Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Entecavir is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. ( 1 )