Insulin Glargine Recombinant

For diabetes mellitus. Sold as Lantus, Lantus Solostar, Toujeo Solostar, Toujeo Max Solostar. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 2 applications for Insulin Glargine Recombinant (sold as Lantus, Lantus Solostar, Toujeo Solostar and others), first approved Apr 20, 2000, with 5 new uses approved and 0 published complete response letters.

First approved: Apr 20, 2000
Applications: 2
New uses approved: 5
Complete response letters: 0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

LANTUS 100 UNIT/ML VIAL: $6.15 per MLBrand · 0% in a year
LANTUS SOLOSTAR 100 UNIT/ML: $6.16 per MLBrand · 0% in a year
TOUJEO SOLOSTAR 300 UNIT/ML: $91.28 per MLBrand · 0% in a year

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes StudyCardiovascular Events, Type2 Diabetes · Brigham and Women's Hospital	—	Active, not recruiting	Feb 2, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 20, 2000	Lantus, Lantus SolostarBLA 21081 · New molecular entity	Sanofi Aventis US	28	Marketed
Feb 25, 2015	Toujeo Solostar, Toujeo Max SolostarBLA 206538 · New formulation or manufacturer	Sanofi US Services	11	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA