FDA — authorised 25 March 2004
- Application: BLA021765
- Marketing authorisation holder: EMD SERONO
- Local brand name: GONAL-F
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 Gonal -f® [r-hFSH] in United States
FDA authorised Gonal -f® [r-hFSH] on 25 March 2004
Marketing authorisations
FDA — authorised 25 May 2004
- Application: BLA021684
- Marketing authorisation holder: EMD SERONO
- Local brand name: GONAL-F RFF REDI-JECT
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA
- Status: approved
Gonal -f® [r-hFSH] 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® [r-hFSH] approved in United States?
Yes. FDA authorised it on 25 March 2004; FDA authorised it on 25 May 2004; FDA has authorised it.
Who is the marketing authorisation holder for Gonal -f® [r-hFSH] in United States?
EMD SERONO holds the US marketing authorisation.