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Dovato Approval History

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 a once-daily, single-tablet, two-drug regimen of the approved drugs dolutegravir (Tivicay) and lamivudine (Epivir) indicated for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either dolutegravir or lamivudine.

Development History and FDA Approval Process for Dovato

DateArticle
Apr  8, 2019Approval FDA Approves Dovato (dolutegravir/lamivudine) for HIV-1 Infection
Oct 18, 2018ViiV Healthcare Submits New Drug Application to FDA for Single-Tablet, Two-Drug Regimen of Dolutegravir and Lamivudine for Treatment of HIV
Aug 16, 2016ViiV Healthcare Launches Phase III Programme Evaluating a Two-Drug Regimen Combining Dolutegravir and Lamivudine for HIV-1 Treatment

Further information

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