🇺🇸 Elrexfio in United States

FDA authorised Elrexfio on 14 August 2023

Marketing authorisation

FDA — authorised 14 August 2023

Application: BLA761345
Marketing authorisation holder: PFIZER INC
Local brand name: ELREXFIO
Indication: SOLUTION — INJECTION
Status: approved

The FDA approved Elrexfio, developed by Pfizer Inc, for its approved indication. The approval was granted through a standard expedited pathway. The application number for this approval is BLA761345.

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Elrexfio in other countries

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

Other Oncology approved in United States

Frequently asked questions

Is Elrexfio approved in United States?

Yes. FDA authorised it on 14 August 2023.

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

PFIZER INC holds the US marketing authorisation.