Tresiba

For diabetes mellitus. BLA 203314, held by Novo. Insulin Degludec.

As of Nov 13, 2026, BLA 203314 (Tresiba), held by Novo, was first approved by FDA on Sep 25, 2015, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2015
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TRESIBA is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use

Not recommended for the treatment of diabetic ketoacidosis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jul 1, 2022	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 9, 2018	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 26, 2018	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Dec 16, 2016	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 25, 2015	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review Pediatric CDTL Review

Products

3 strengths and forms

Product	Active ingredient	Marketing
Tresiba300 UNITS/3ML (100 UNITS/ML) · solution;subcutaneous	Insulin Degludec	Rx
Tresiba600 UNITS/3ML (200 UNITS/ML) · solution;subcutaneous	Insulin Degludec	Rx
Tresiba1000 UNITS/10ML (100 UNITS/ML) · solution;subcutaneous	Insulin Degludec	Rx

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 1, 2022	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 1, 2022	Supplement 18Labeling · Standard review	Approved	Letter Label
Nov 15, 2019	Supplement 16Labeling	Approved	Letter Label
Nov 15, 2019	Supplement 15Labeling · Standard review	Approved	Label Letter
Nov 21, 2018	Supplement 10Labeling · Standard review	Approved	Letter Label
Aug 9, 2018	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 26, 2018	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Dec 16, 2016	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 8, 2016	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 24, 2016	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 25, 2015	Original applicationNew molecular entity · Standard review	Approved	Letter Label Review Pediatric CDTL Review

Identifiers

Application: BLA 203314
Drugs@FDA: Overview at FDA
Company: Novo

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