🇺🇸 IMDELLTRA in United States

FDA authorised IMDELLTRA on 16 May 2024

Marketing authorisation

FDA — authorised 16 May 2024

Application: BLA761344
Marketing authorisation holder: AMGEN INC
Local brand name: IMDELLTRA
Indication: INJECTABLE — INJECTION
Status: approved

The FDA approved IMDELLTRA, a new molecular entity, on 16 May 2024, under the standard expedited pathway. The marketing authorisation holder is AMGEN INC. The indication approved for IMDELLTRA is Type 1, which is a new molecular entity. This approval was granted based on the BLA761344 application.

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IMDELLTRA in other countries

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

Other Other approved in United States

Frequently asked questions

Is IMDELLTRA approved in United States?

Yes. FDA authorised it on 16 May 2024.

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

AMGEN INC holds the US marketing authorisation.