🇺🇸 GONAL-f® in United States

FDA authorised GONAL-f® on 25 March 2004

Marketing authorisations

FDA — authorised 25 March 2004

  • Application: BLA021765
  • Marketing authorisation holder: EMD SERONO
  • Local brand name: GONAL-F
  • Indication: INJECTABLE — SUBCUTANEOUS
  • Status: approved

Read official source →

FDA

  • Status: approved

GONAL-f® in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is GONAL-f® approved in United States?

Yes. FDA authorised it on 25 March 2004; FDA has authorised it.

Who is the marketing authorisation holder for GONAL-f® in United States?

EMD SERONO holds the US marketing authorisation.