LILLY — Humalog Mix 50/50 FDA Review (NDA/BLA 021018, 2020)
Eli Lilly and Company · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Humalog Mix 50/50, a pre-mixed insulin product by Eli Lilly & Co., approved in 2007 for hyperglycemia control. It covers its pharmacokinetics, pharmacodynamics, and clinical efficacy compared to Regular human insulin. The document also includes information on Humalog (insulin lispro injection), Humalog Mix75/25, and their use in various delivery devices, including KwikPen™ disposable injectors. Specific sections address indications, contraindications, warnings, precautions, adverse reactions, storage, and considerations for special populations. Regulatory reviews of proprietary names and packaging for the KwikPen line are also included, highlighting efforts to mitigate medication errors through design and labeling, and the eventual phasing out of older pen devices.
Key findings — cited to the page
| Reading grade level of Patient Package Insert (PPI) | 9.3 | · p.89 |
| Revised reading grade level of Patient Package Insert (PPI) | 7.9 | · p.89 |
| Fasting Blood Glucose (Type 1 diabetes) | 209.5 ± 91.6 mg/dL | · p.20 |
| Approval Date | September 06, 2007 | HUMALOG Mix 50/50 · p.1 |
| Number of patients in cross-over studies (Type 2 diabetes) | 722 patients | · p.20 |
| NDA Number | 21-017/S-040 | Humalog Mix 75/25 KwikPen · p.71 |
| Planned discontinuation period for existing Pen injector device | 3 years | Humalog KwikPen · p.76 |
| NDA Number | 21-018/S-034 | Humalog Mix 50/50 KwikPen · p.71 |
| Number of patients using existing prefilled Pen | 250,000 patients | Humalog Pen · p.82 |
| Application Number | 021018Orig1s034 | HUMALOG Mix 50/50 · p.1 |
| NDA Number | 20-563/S-075 | Humalog KwikPen · p.71 |
| Indication | treatment of patients with diabetes mellitus for the control of hyperglycemia | HUMALOG Mix 50/50 · p.1 |
Source: Eli Lilly and Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →