REYATAZ (atazanavir sulfate) · Bristol-Myers Squibb
Reyataz is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 3 months of age and older weighing at least 5 kg. It is not recommended for use in pediatric patients younger than 3 months due to the risk of kernicterus. In treatment-experienced patients, the use of Reyataz with ritonavir should be guided by the number of baseline primary protease inhibitor resistance substitutions.
How REYATAZ Works
Atazanavir is an HIV-1 protease inhibitor. It works by selectively inhibiting the virus-specific processing of viral Gag and Gag-Pol polyproteins in HIV-1 infected cells. This prevents the formation of mature, infectious virions, thereby interrupting the viral replication cycle.
Details
- Status
- Prescription
- First Approved
- 2003-06-20
- Routes
- ORAL
- Dosage Forms
- POWDER, CAPSULE
REYATAZ Approval History
What REYATAZ Treats
1 indicationsREYATAZ is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
REYATAZ Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Bristol-Myers Squibb's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REYATAZ FDA Label Details
Indications & Usage
FDA Label (PDF)REYATAZ ® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 3 months and older weighing at least 5 kg. Limitations of Use: • REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations ] . • Use of REYATAZ with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology ] . REYATAZ is a protease inhibitor indicated for use in comb...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.