FDA — authorised 28 October 1982
- Application: BLA018780
- Marketing authorisation holder: LILLY
- Local brand name: HUMULIN R KWIKPEN
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 INSULIN HUMAN in United States
FDA authorised INSULIN HUMAN on 28 October 1982 · 4,617 US adverse-event reports
Marketing authorisations
FDA — authorised 26 July 1996
- Application: BLA018781
- Marketing authorisation holder: LILLY
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 9 November 2005
- Application: BLA019717
- Marketing authorisation holder: LILLY
- Indication: Labeling
- Status: approved
FDA — authorised 20 June 2019
- Application: BLA208157
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 23 January 2026
- Application: BLA022472
- Marketing authorisation holder: MANNKIND
- Indication: Efficacy
- Status: approved
The FDA approved INSULIN HUMAN for the indication of efficacy. This approval was granted to MANNKIND, the marketing authorisation holder, on 23 January 2026. The application number for this approval is BLA022472.
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: 4,617
Most-reported reactions
- Blood Glucose Increased — 1,116 reports (24.17%)
- Hypoglycaemia — 526 reports (11.39%)
- Drug Ineffective — 423 reports (9.16%)
- Dyspnoea — 419 reports (9.08%)
- Diarrhoea — 382 reports (8.27%)
- Nausea — 376 reports (8.14%)
- Hyperglycaemia — 366 reports (7.93%)
- Blood Glucose Decreased — 355 reports (7.69%)
- Vomiting — 336 reports (7.28%)
- Fall — 318 reports (6.89%)
INSULIN HUMAN 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 INSULIN HUMAN approved in United States?
Yes. FDA authorised it on 28 October 1982; FDA authorised it on 26 July 1996; FDA authorised it on 9 November 2005.
Who is the marketing authorisation holder for INSULIN HUMAN in United States?
LILLY holds the US marketing authorisation.