🇺🇸 Cabotegravir long-acting in United States

FDA authorised Cabotegravir long-acting on 21 January 2021

Marketing authorisation

FDA — authorised 21 January 2021

  • Application: NDA212888
  • Marketing authorisation holder: VIIV HLTHCARE
  • Local brand name: CABENUVA KIT
  • Indication: SUSPENSION, EXTENDED RELEASE — INTRAMUSCULAR
  • Status: approved

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Frequently asked questions

Is Cabotegravir long-acting approved in United States?

Yes. FDA authorised it on 21 January 2021.

Who is the marketing authorisation holder for Cabotegravir long-acting in United States?

VIIV HLTHCARE holds the US marketing authorisation.