dolutegravir sodium
dolutegravir sodium is listed in the FDA National Drug Code directory with 14 NDC codes, marketed under brand names including Tivicay PD, Tivicay. Available dosage forms: tablet, for suspension, tablet, film coated, powder.
Drug Details
- Generic Name
- dolutegravir sodium
- Brand Names
- Tivicay PD, Tivicay
- Application Number
- NDA213983
- Sponsor
- ViiV Healthcare Company
- NDC Codes
- 14
- Dosage Forms
- TABLET, FOR SUSPENSION, TABLET, FILM COATED, POWDER
- Routes
- ORAL
- Active Ingredients
- DOLUTEGRAVIR SODIUM
Indications and Usage
1 INDICATIONS AND USAGE DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or 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 treatment failure and no known substitutions associated with resistance to the individual components of DOVATO. DOVATO, a two-drug combination of dolutegravir (integrase strand transfer inhibitor [INSTI]) and lamivudine (nucleoside analogue reverse transcriptase inhibitor [NRTI]) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or 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 treatment failure and no known substitutions associated with resistance to the individual components of DOVATO. ( 1 )