tenofovir alafenamide

FDA Drug Profile — VEMLIDY

Drug Details

Generic Name
tenofovir alafenamide
Brand Names
VEMLIDY
Application Number
NDA208464
Sponsor
Gilead Sciences, Inc.
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
TENOFOVIR ALAFENAMIDE FUMARATE

Indications and Usage

1 INDICATIONS AND USAGE VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease [see Clinical Studies (14) ] . VEMLIDY is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease. ( 1 )