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Data updated: May 26, 2026

NOVOLOG MIX 70/30 (insulin aspart protamine recombinant)

Metabolic Approved 2001-11-01

NOVOLOG MIX 70/30 is an insulin analog indicated to improve glycemic control in adult patients with diabetes mellitus. The product is a fixed-ratio mixture containing insulin aspart protamine, an intermediate-acting insulin, and insulin aspart, a rapid-acting insulin. Due to these fixed proportions, the medication does not allow for separate basal and prandial dose adjustments and is not recommended for the treatment of diabetic ketoacidosis.

Source: FDA Label • Novo Nordisk • Insulin Analog

How NOVOLOG MIX 70/30 Works

This medication regulates glucose metabolism by lowering blood glucose levels through multiple biological pathways. It stimulates peripheral glucose uptake, particularly in skeletal muscle and fat, and inhibits the production of glucose by the liver. Furthermore, the drug enhances protein synthesis while simultaneously inhibiting the processes of lipolysis and proteolysis.

3
Indications
--
Phase 3 Trials
1
Priority Reviews
24
Years on Market

Details

Status
Prescription
First Approved
2001-11-01
Routes
SUBCUTANEOUS
Dosage Forms
INJECTABLE

NOVOLOG MIX 70/30 Approval History

2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
34 FDA actions from 2001 to 2023 · 2 indication expansions
Feb 2023 SUPPL
Label · Labeling
Apr 2021 SUPPL
Label · Labeling
Nov 2019 SUPPL
Label · Labeling

What NOVOLOG MIX 70/30 Treats

1 indications

NOVOLOG MIX 70/30 is approved for 1 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Diabetes
Source: FDA Label

NOVOLOG MIX 70/30 Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in NOVOLOG MIX 70/30's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NOVOLOG MIX 70/30 treats. First-in-class if their pivotal trials read out positive.

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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NOVOLOG MIX 70/30 FDA Label Details

Indications & Usage

FDA Label (PDF)

NOVOLOG MIX 70/30 is indicated for the treatment of Diabetes.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.