Doravirine, Islatravir
Doravirine, Islatravir is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including IDVYNSO. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- Doravirine, Islatravir
- Brand Names
- IDVYNSO
- Application Number
- NDA216964
- Sponsor
- Merck Sharp & Dohme LLC
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- DORAVIRINE, ISLATRAVIR ANHYDROUS
Indications and Usage
1 INDICATIONS AND USAGE IDVYNSO™ is indicated as a complete two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine [see Microbiology (12.4) and Clinical Studies (14) ]. IDVYNSO is a two-drug combination of doravirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), and islatravir, a nucleoside analog reverse transcriptase inhibitor (NRTI), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. ( 1 )