🇺🇸 TYENNE in United States

FDA authorised TYENNE on 5 March 2024

Marketing authorisations

FDA — authorised 5 March 2024

  • Application: BLA761275
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: TYENNE
  • Indication: INJECTABLE — INTRAVENOUS
  • Status: approved

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FDA — authorised 14 March 2025

  • Application: BLA761449
  • Marketing authorisation holder: FRESENIUS KABI USA
  • Local brand name: TYENNE
  • Indication: INJECTABLE — SUBCUTANEOUS
  • Status: approved

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FDA

  • Status: approved

TYENNE 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 TYENNE approved in United States?

Yes. FDA authorised it on 5 March 2024; FDA authorised it on 14 March 2025; FDA has authorised it.

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

FRESENIUS KABI USA holds the US marketing authorisation.