tenofovir disoproxil fumarate
Drug Details
- Generic Name
- tenofovir disoproxil fumarate
- Brand Names
- TENOFOVIR DISOPROXIL FUMARATE, tenofovir disoproxil fumarate
- Application Number
- ANDA090742
- Sponsor
- Strides Pharma Science Limited
- NDC Codes
- 6
- Dosage Forms
- TABLET, TABLET, COATED, TABLET, FILM COATED, POWDER
- Routes
- ORAL
- Active Ingredients
- TENOFOVIR DISOPROXIL FUMARATE
Indications and Usage
1 INDICATIONS AND USAGE Tenofovir disoproxil fumarate is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. ( 1.1 ) for the treatment of chronic hepatitis B in adults and pediatric patients 12 years and older. ( 1.2 ) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. 1.2 Chronic Hepatitis B Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B virus (HBV) in adults and pediatric patients 12 years of age and older. Pediatric use information is approved for Gilead Sciences, Inc.'s VIREAD® (tenofovir disoproxil fumarate) tablets. However, due to Gilead Sciences, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information