atazanavir and cobicistat
Drug Details
- Generic Name
- atazanavir and cobicistat
- Brand Names
- EVOTAZ
- Application Number
- NDA206353
- Sponsor
- E.R. Squibb & Sons, L.L.C.
- NDC Codes
- 1
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- ATAZANAVIR SULFATE, COBICISTAT
Indications and Usage
1 INDICATIONS AND USAGE EVOTAZ is a two-drug combination of atazanavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults and pediatric patients weighing at least 35 kg. (1) Limitations of Use Use of EVOTAZ in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions. (1) 1.1 Indications EVOTAZ ® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in the following populations [see Dosage and Administration (2.2 , 2.3) ] : • Adult patients • Pediatric patients weighing at least 35 kg. 1.2 Limitations of Use Use of EVOTAZ in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Clinical Pharmacology (12.4) ] .