Toujeo Solostar, Toujeo Max Solostar

For diabetes mellitus. BLA 206538, held by Sanofi US Services. Insulin Glargine Recombinant.

As of Nov 13, 2026, BLA 206538 (Toujeo Solostar, Toujeo Max Solostar), held by Sanofi US Services, was first approved by FDA on Feb 25, 2015, with 11 approved supplements and 0 published complete response letters.

First approved: Feb 25, 2015
Review: Standard
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Nov 26, 2019	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Label
Feb 25, 2015	Original applicationNew formulation or manufacturer · Standard review	Approved	Letter Review Label Summary Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Toujeo Solostar450 UNITS/1.5ML (300 UNITS/ML) · solution;subcutaneous	Insulin Glargine Recombinant	Rx
Toujeo Max Solostar900 UNITS/3ML (300 UNITS/ML) · solution;subcutaneous	Insulin Glargine Recombinant	Rx

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 29, 2024	Supplement 17Labeling · Standard review	Approved	Label Letter
Aug 16, 2022	Supplement 16Labeling · Standard review	Approved	Letter Label
Nov 26, 2019	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Label
Nov 15, 2019	Supplement 14Labeling · Standard review	Approved	Letter Label
Nov 15, 2019	Supplement 13Labeling · Standard review	Approved	Label Letter
Oct 25, 2018	Supplement 11Manufacturing	Approved	Label
Oct 25, 2018	Supplement 10Labeling · Standard review	Approved	Label
Mar 26, 2018	Supplement 6Labeling · Standard review	Approved	Letter Label
Nov 23, 2016	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 16, 2016	Supplement 2Manufacturing · Standard review	Approved	None posted
Sep 29, 2015	Supplement 1Manufacturing · Standard review	Approved	Letter
Feb 25, 2015	Original applicationNew formulation or manufacturer · Standard review	Approved	Letter Review Label Summary Review

Identifiers

Application: BLA 206538
Drugs@FDA: Overview at FDA
Company: Sanofi US Services

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters