🇺🇸 TENOFOVIR ALAFENAMIDE FUMARATE in United States

FDA authorised TENOFOVIR ALAFENAMIDE FUMARATE on 23 February 2024

Marketing authorisations

FDA — authorised 23 February 2024

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

The FDA approved TENOFOVIR ALAFENAMIDE FUMARATE for its efficacy indication. This approval was granted to GILEAD SCIENCES INC, the marketing authorisation holder, following a standard expedited pathway. The application number for this approval is NDA210251.

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FDA — authorised 21 March 2024

Application: ANDA213867
Marketing authorisation holder: APOTEX
Local brand name: TENOFOVIR ALAFENAMIDE FUMARATE
Indication: TABLET — ORAL
Status: approved

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FDA

Application: ANDA214030
Marketing authorisation holder: LAURUS LABS LTD
Local brand name: TENOFOVIR ALAFENAMIDE FUMARATE
Indication: TABLET — ORAL
Status: approved

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TENOFOVIR ALAFENAMIDE FUMARATE in other countries

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

Frequently asked questions

Is TENOFOVIR ALAFENAMIDE FUMARATE approved in United States?

Yes. FDA authorised it on 23 February 2024; FDA authorised it on 21 March 2024; FDA has authorised it.

Who is the marketing authorisation holder for TENOFOVIR ALAFENAMIDE FUMARATE in United States?

GILEAD SCIENCES INC holds the US marketing authorisation.