FDA — authorised 18 September 1986
- Marketing authorisation holder: SERONO
- Status: approved
🇺🇸 Urofollitropin in United States
FDA authorised Urofollitropin on 18 September 1986
Marketing authorisations
FDA — authorised 18 September 1986
- Application: NDA019415
- Marketing authorisation holder: SERONO
- Local brand name: METRODIN
- Indication: INJECTABLE — INTRAMUSCULAR
- Status: approved
FDA — authorised 26 March 2001
- Application: BLA020378
- Marketing authorisation holder: EMD SERONO
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 6 February 2013
- Application: BLA021684
- Marketing authorisation holder: EMD SERONO
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 15 November 2016
- Application: BLA021211
- Marketing authorisation holder: ORGANON USA LLC
- Indication: Manufacturing (CMC)
- Status: approved
Urofollitropin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Urofollitropin approved in United States?
Yes. FDA authorised it on 18 September 1986; FDA authorised it on 18 September 1986; FDA authorised it on 26 March 2001.
Who is the marketing authorisation holder for Urofollitropin in United States?
SERONO holds the US marketing authorisation.