🇺🇸 Dolutegravir (DTG) in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Dolutegravir (DTG) on 12 August 2013

Marketing authorisation

FDA — authorised 12 August 2013

Application: NDA204790
Marketing authorisation holder: VIIV HLTHCARE
Local brand name: TIVICAY
Indication: TABLET — ORAL
Status: approved

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Other Infectious Disease approved in United States

Frequently asked questions

Is Dolutegravir (DTG) approved in United States?

Yes. FDA authorised it on 12 August 2013.

Who is the marketing authorisation holder for Dolutegravir (DTG) in United States?

VIIV HLTHCARE holds the US marketing authorisation.