Saxenda

For body weight greater than 60 kg and obesity. NDA 206321, held by Novo. Liraglutide.

As of Nov 15, 2026, NDA 206321 (Saxenda), held by Novo, was first approved by FDA on Dec 23, 2014, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 23, 2014
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SAXENDA is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in:

Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity.
Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use
SAXENDA contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.
The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Dec 4, 2020	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 25, 2020	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 19, 2018	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 26, 2017	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 23, 2014	Original applicationNew indication · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Saxenda18MG/3ML (6MG/ML) · solution;subcutaneous	Liraglutide	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Jun 2, 2026	Supplement 24Labeling · Standard review	Approved	Label Letter
Feb 25, 2026	Supplement 25Labeling · Standard review	Approved	Label Letter
Oct 14, 2025	Supplement 22Labeling · Standard review	Approved	Letter Label Medication Guide
May 28, 2025	Supplement 20Labeling · Standard review	Approved	Label Letter
Nov 1, 2024	Supplement 19Labeling	Approved	Letter Label
Apr 20, 2023	Supplement 16Labeling · Standard review	Approved	Label Letter
Jun 15, 2022	Supplement 15Labeling · Standard review	Approved	Letter Label
Dec 4, 2020	Supplement 14Labeling · Standard review	Approved	Label Letter
Dec 4, 2020	Supplement 13Labeling · Standard review	Approved	Label Letter
Dec 4, 2020	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 25, 2020	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 4, 2018	Supplement 9REMS	Approved	Letter
Oct 19, 2018	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 22, 2017	Supplement 5REMS	Approved	Letter
Apr 26, 2017	Supplement 6Labeling · Standard review	Approved	Letter Label
Apr 26, 2017	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 22, 2016	Supplement 3Labeling · Standard review	Approved	Letter Label
Feb 1, 2016	Supplement 2REMS	Approved	Letter
Mar 27, 2015	Supplement 1Labeling · Standard review	Approved	Label Letter
Dec 23, 2014	Original applicationNew indication · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 206321
Drugs@FDA: Overview at FDA
Company: Novo

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