Xultophy 100/3.6

For type 2 diabetes mellitus. BLA 208583, held by Novo. Insulin Degludec; Liraglutide.

As of Nov 13, 2026, BLA 208583 (Xultophy 100/3.6), held by Novo, was first approved by FDA on Nov 21, 2016, with 15 approved supplements and 0 published complete response letters.

First approved: Nov 21, 2016
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

XULTOPHY 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use:

XULTOPHY 100/3.6 contains liraglutide. Coadministration with any other product containing liraglutide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.
XULTOPHY 100/3.6 is not recommended for the treatment of diabetic ketoacidosis.
XULTOPHY 100/3.6 has not been studied in combination with prandial insulin.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Aug 8, 2019	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 27, 2019	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Letter
Feb 27, 2019	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 27, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 1, 2019	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 1, 2019	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 21, 2016	Original applicationNew combination · Standard review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xultophy 100/3.6300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML) · solution;subcutaneous	Insulin Degludec; Liraglutide	Rx

All 16 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 14, 2025	Supplement 26Labeling · Standard review	Approved	Letter Label Medication Guide
May 28, 2025	Supplement 25Labeling · Standard review	Approved	Label Letter
Nov 1, 2024	Supplement 24Labeling	Approved	Letter Label
Jul 10, 2023	Supplement 21Labeling · Standard review	Approved	Label Letter
Jun 10, 2022	Supplement 18Labeling · Standard review	Approved	Letter Label
Jun 10, 2022	Supplement 19Labeling	Approved	Letter Label
Nov 15, 2019	Supplement 14Labeling · Standard review	Approved	Label Letter
Nov 15, 2019	Supplement 15Labeling	Approved	Label Letter
Aug 8, 2019	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 27, 2019	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Letter
Feb 27, 2019	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 27, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 1, 2019	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 1, 2019	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 12, 2017	Supplement 1REMS	Approved	Letter
Nov 21, 2016	Original applicationNew combination · Standard review	Approved	Letter Label Review

Identifiers

Application: BLA 208583
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