FDA — authorised 25 May 1995
- Application: BLA019774
- Marketing authorisation holder: FERRING
- Local brand name: BIO-TROPIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Omnitrope in United States
FDA authorised Omnitrope on 25 May 1995 · 9,053 US adverse-event reports
Marketing authorisations
FDA — authorised 29 December 1995
- Application: BLA020522
- Marketing authorisation holder: GENENTECH
- Local brand name: NUTROPIN AQ NUSPIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 May 2006
- Application: BLA021426
- Marketing authorisation holder: SANDOZ
- Local brand name: OMNITROPE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 9,053
Most-reported reactions
- Injection Site Pain — 1,489 reports (16.45%)
- Device Breakage — 1,259 reports (13.91%)
- Device Leakage — 1,099 reports (12.14%)
- Incorrect Dose Administered — 1,015 reports (11.21%)
- Incorrect Dose Administered By Device — 1,006 reports (11.11%)
- Device Issue — 746 reports (8.24%)
- Product Dose Omission Issue — 691 reports (7.63%)
- Circumstance Or Information Capable Of Leading To Medication Error — 637 reports (7.04%)
- Drug Dose Omission By Device — 565 reports (6.24%)
- Headache — 546 reports (6.03%)
Omnitrope 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 Omnitrope approved in United States?
Yes. FDA authorised it on 25 May 1995; FDA authorised it on 29 December 1995; FDA authorised it on 30 May 2006.
Who is the marketing authorisation holder for Omnitrope in United States?
FERRING holds the US marketing authorisation.