🇺🇸 Biktarvy in United States

FDA authorised Biktarvy on 23 February 2024

Marketing authorisation

FDA — authorised 23 February 2024

  • Application: NDA210251
  • Marketing authorisation holder: GILEAD SCIENCES INC
  • Indication: Efficacy
  • Status: approved

Gilead Sciences Inc's Biktarvy has been granted marketing authorisation by the FDA in the United States. This authorisation was approved on 23 February 2024, following a standard expedited pathway. Biktarvy is a treatment for a specific indication, as per the approved efficacy.

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Biktarvy in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology approved in United States

Frequently asked questions

Is Biktarvy approved in United States?

Yes. FDA authorised it on 23 February 2024.

Who is the marketing authorisation holder for Biktarvy in United States?

GILEAD SCIENCES INC holds the US marketing authorisation.