🇺🇸 Liposomal daunorubicin in United States

FDA authorised Liposomal daunorubicin on 8 April 1996

Marketing authorisation

FDA — authorised 8 April 1996

  • Application: NDA050704
  • Marketing authorisation holder: GALEN (UK)
  • Local brand name: DAUNOXOME
  • Indication: INJECTABLE, LIPOSOMAL — INJECTION
  • Status: approved

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Other Oncology approved in United States

Frequently asked questions

Is Liposomal daunorubicin approved in United States?

Yes. FDA authorised it on 8 April 1996.

Who is the marketing authorisation holder for Liposomal daunorubicin in United States?

GALEN (UK) holds the US marketing authorisation.