FDA — authorised 23 November 1999
- Application: BLA017692
- Marketing authorisation holder: ORGANON USA LLC
- Indication: Labeling
- Status: approved
🇺🇸 Ovidrel in United States
FDA authorised Ovidrel on 23 November 1999
Marketing authorisations
FDA — authorised 20 September 2000
- Marketing authorisation holder: EMD SERONO
- Status: approved
FDA — authorised 30 July 2007
- Application: BLA021149
- Marketing authorisation holder: EMD SERONO
- Indication: Labeling
- Status: approved
Ovidrel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Ovidrel approved in United States?
Yes. FDA authorised it on 23 November 1999; FDA authorised it on 20 September 2000; FDA authorised it on 30 July 2007.
Who is the marketing authorisation holder for Ovidrel in United States?
ORGANON USA LLC holds the US marketing authorisation.