FDA — authorised 20 October 1976
- Application: BLA017692
- Marketing authorisation holder: ORGANON USA LLC
- Local brand name: PREGNYL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 low dose hCG in United States
FDA authorised low dose hCG on 20 October 1976
Marketing authorisations
FDA
- Status: approved
low dose hCG 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 low dose hCG approved in United States?
Yes. FDA authorised it on 20 October 1976; FDA has authorised it.
Who is the marketing authorisation holder for low dose hCG in United States?
ORGANON USA LLC holds the US marketing authorisation.