FDA — authorised 24 August 1995
- Application: BLA020280
- Marketing authorisation holder: PHARMACIA
- Local brand name: GENOTROPIN PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Omnitrope in United States
FDA authorised Omnitrope on 24 August 1995
Marketing authorisations
FDA
- Status: approved
Omnitrope 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 Omnitrope approved in United States?
Yes. FDA authorised it on 24 August 1995; FDA has authorised it.
Who is the marketing authorisation holder for Omnitrope in United States?
PHARMACIA holds the US marketing authorisation.