Dovato FDA Approval History
Last updated by Judith Stewart, BPharm on April 9, 2024.
FDA Approved: Yes (First approved April 8, 2019)
Brand name: Dovato
Generic name: dolutegravir and lamivudine
Dosage form: Tablets
Company: ViiV Healthcare
Treatment for: HIV Infection
Dovato (dolutegravir and lamivudine) is an integrase strand transfer inhibitor and nucleoside analogue reverse transcriptase inhibitor combination used for the treatment of HIV-1 infection.
- 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 is administered orally once daily, with or without food.
- Common adverse reactions include headache, nausea, diarrhea, insomnia, fatigue, and anxiety.
Development timeline for Dovato
Further information
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