Atazanavir
Drug Details
- Generic Name
- Atazanavir
- Brand Names
- Atazanavir, Atazanavir Sulfate
- Application Number
- ANDA212579
- Sponsor
- Catalent Pharma Solutions, LLC
- NDC Codes
- 16
- Dosage Forms
- POWDER, CAPSULE
- Routes
- ORAL
- Active Ingredients
- ATAZANAVIR SULFATE
Indications and Usage
1 INDICATIONS AND USAGE Atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4) ]. Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4) ] . Atazanavir capsule is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. ( 1 )