🇺🇸 Cytalux in United States

FDA authorised Cytalux on 29 November 2021

Marketing authorisations

FDA — authorised 29 November 2021

  • Marketing authorisation holder: ON TARGET LABROTORIES, INC
  • Status: approved

FDA — authorised 29 November 2021

  • Application: NDA214907
  • Marketing authorisation holder: ON TARGET LABS
  • Local brand name: CYTALUX
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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Cytalux 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 Cytalux approved in United States?

Yes. FDA authorised it on 29 November 2021; FDA authorised it on 29 November 2021.

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

ON TARGET LABROTORIES, INC holds the US marketing authorisation.