🇺🇸 IMULDOSA in United States

FDA authorised IMULDOSA on 10 October 2024

Marketing authorisation

FDA — authorised 10 October 2024

  • Application: BLA761364
  • Marketing authorisation holder: ACCORD BIOPHARMA INC.
  • Local brand name: IMULDOSA
  • Indication: INJECTABLE — INTRAVENOUS
  • Status: approved

The FDA granted marketing authorisation to IMULDOSA on 17 March 2025, for its approved indication. IMULDOSA is a drug developed by ACCORD BIOPHARMA INC. The marketing authorisation was granted through a standard expedited pathway. The approved indication for IMULDOSA is listed in its labelling.

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IMULDOSA 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 IMULDOSA approved in United States?

Yes. FDA authorised it on 10 October 2024.

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

ACCORD BIOPHARMA INC. holds the US marketing authorisation.