NOVO NORDISK INC — Levemir FDA Review (NDA/BLA 021536, 2020)
NOVO NORDISK INC · 2020 · FDA Review (Drugs@FDA)
Report summary
This FDA approval package details the 2007 approval of a supplemental new drug application for Novo Nordisk's Levemir (insulin detemir). The core of the approval concerned a formulation change in the 3 mL PenFill Cartridges, replacing mannitol with glycerol as the isotonic agent. Bioequivalence between the old and new formulations was confirmed through clinical trials. The document comprehensively covers Levemir's product information, including dosage for Type 1 and Type 2 diabetes, administration guidelines, storage, contraindications, and potential side effects like hypoglycemia and hyperglycemia. It also summarizes efficacy and safety data from clinical studies comparing Levemir to NPH human insulin and insulin glargine in both adult and pediatric patients.
Key findings — cited to the page
| PDUFA goal date | 17-May-2007 | Levemir · p.50 |
| NDA status | acceptable | Levemir · p.55 |
| Terminal half-life | 5 to 7 hours | Levemir · p.10 |
| Review date | 11-Apr-2007 | Levemir · p.50 |
| Approval status | Approval | Levemir · p.51 |
| Clinical Pharmacology Review date | January 17, 2007 | Levemir · p.54 |
| Absolute bioavailability | 60 % | Levemir · p.10 |
| Apparent volume of distribution | 0.1 L/kg | Levemir · p.10 |
| NDA number | 21-536 | Levemir · p.49 |
| Supplement number | SCF-015 | Levemir · p.50 |
| Submission date | 17-Jan-2007 | Levemir · p.50 |
| bioequivalence study design | randomized, single centre, two-way crossover | NN304-1685 · p.57 |
Source: NOVO NORDISK INC ↗ · 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 →