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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.

Development timeline for Dovato

DateArticle
Apr  8, 2024Approval ViiV Healthcare Announces U.S. FDA Approval of Dovato (dolutegravir/lamivudine) for Adolescents Living with HIV
Aug  6, 2020Approval ViiV Healthcare Announces FDA Approval of an Expanded Indication for Dovato (dolutegravir/lamivudine), a Complete Two-Drug Regimen for Virologically Suppressed Adults with HIV-1
Apr  8, 2019Approval FDA Approves Dovato (dolutegravir/lamivudine) for HIV-1 Infection in Adults with No Antiretroviral (ARV) Treatment History
Oct 18, 2018ViiV Healthcare Submits New Drug Application to FDA for Single-Tablet, Two-Drug Regimen of Dolutegravir and Lamivudine for Treatment of HIV

Further information

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