FDA — authorised 25 March 2004
- Application: BLA021765
- Marketing authorisation holder: EMD SERONO
- Local brand name: GONAL-F RFF
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA authorised Gonal-f® RFF on 25 March 2004
Yes. FDA authorised it on 25 March 2004.
EMD SERONO holds the US marketing authorisation.