🇺🇸 Ferric Carboxymaltose (FCM) in United States

FDA authorised Ferric Carboxymaltose (FCM) on 25 July 2013

Marketing authorisation

FDA — authorised 25 July 2013

  • Application: NDA203565
  • Marketing authorisation holder: AM REGENT
  • Local brand name: INJECTAFER
  • Indication: SOLUTION — INTRAVENOUS
  • Status: approved

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Other Hematology approved in United States

Frequently asked questions

Is Ferric Carboxymaltose (FCM) approved in United States?

Yes. FDA authorised it on 25 July 2013.

Who is the marketing authorisation holder for Ferric Carboxymaltose (FCM) in United States?

AM REGENT holds the US marketing authorisation.