🇺🇸 Poteligeo in United States

FDA authorised Poteligeo on 21 January 2025

Marketing authorisation

FDA — authorised 21 January 2025

  • Application: BLA761051
  • Marketing authorisation holder: KYOWA KIRIN
  • Indication: Labeling
  • Status: approved

The FDA approved Poteligeo, a drug developed by Kyowa Kirin, for labeling indication. This approval was granted through a standard expedited pathway. Poteligeo is a medication intended for use in a specific labeling indication.

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Poteligeo 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 Poteligeo approved in United States?

Yes. FDA authorised it on 21 January 2025.

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

KYOWA KIRIN holds the US marketing authorisation.