Regulatory PathRegulatory requirements compared

Active substance

Insulin recombinant human

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
HUMULIN R100 UNITS/MLinjectable · injectionLILLYOver-the-counter28 Oct 1982
HUMULIN R PEN100 UNITS/MLinjectable · injectionLILLYOver-the-counter28 Oct 1982
NOVOLIN R100 UNITS/MLinjectable · injectionNOVO NORDISK INCOver-the-counter25 Jun 1991
AFREZZA4 UNITS/INH; 8 UNITS/INH; 12 UNITS/INHpowder · inhalationMANNKINDPrescription27 Jun 2014

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACAFREZZA ((REGULAR INSULIN) 8 UNIT CARTRIDGE$10.3754per EA23 Sep 2026
US NADACAFREZZA (REGULAR INSULIN) 12 UNIT CARTRIDGE$15.65297per EA20 May 2026
US NADACAFREZZA (REGULAR INSULIN) 4 UNIT CARTRIDGE$5.20552per EA23 Sep 2026
US NADACAFREZZA (REGULAR INSULIN) 60-4 UNIT/60-8 UNIT/60-12 UNIT$10.33288per EA23 Sep 2026
US NADACAFREZZA (REGULAR INSULIN) 90-4 UNIT / 90-8 UNIT$7.78053per EA23 Sep 2026
US NADACAFREZZA (REGULAR INSULIN) 90-8 UNIT / 90-12 UNIT$13.03769per EA1 Apr 2026
US NADACNOVOLIN R 100 UNIT/ML FLEXPEN$5.81495per ML23 Sep 2026
US NADACNOVOLIN R 100 UNIT/ML VIAL$4.62465per ML23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 29 May 2026 AFREZZA — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 27 Jun 2022 HUMULIN 70/30 — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 27 Jun 2022 HUMULIN 70/30 PEN — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 27 Jun 2022 HUMULIN R PEN — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Nov 2019 NOVOLIN 70/30 — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 15 Nov 2019 NOVOLIN R — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for insulin recombinant human →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.