🇺🇸 Ziihera in United States

FDA authorised Ziihera on 20 November 2024

Marketing authorisations

FDA — authorised 20 November 2024

Application: BLA761416
Marketing authorisation holder: JAZZ PHARMS
Local brand name: ZIIHERA
Indication: INJECTABLE — INJECTION
Status: approved

The FDA approved Ziihera, a new molecular entity, on 20 November 2024, under the standard expedited pathway. The marketing authorisation holder is JAZZ PHARMS. The indication for Ziihera has not been specified in the available information.

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FDA

Marketing authorisation holder: JAZZ PHARMS
Status: approved

Ziihera 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 Ziihera approved in United States?

Yes. FDA authorised it on 20 November 2024; FDA has authorised it.

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

JAZZ PHARMS holds the US marketing authorisation.