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Saxenda
Saxenda is a brand of liraglutide from Novo Nordisk, first approved by the FDA on 2014-12-23 under application NDA206321, authorised in the EU as Saxenda, currently listed in shortage by the FDA (1 record).
Saxenda is Novo Nordisk's brand of liraglutide, approved under NDA206321. The same molecule is also sold as Victoza, Xultophy — a separate application with its own approved uses and its own supply record, which is why the two are tracked apart here rather than merged. Its current FDA label, effective 2026-02-25, covers obesity. 1 presentation is currently listed on the FDA shortage database. It is also authorised in the EU, which does not always follow the US indication wording.
Saxenda and Victoza, Xultophy are the same molecule. They are marketed under separate FDA applications with different approved indications, so they are distinct products on the regulatory record even though the active ingredient is identical. Compare the applications below. Side by side: Saxenda vs Victoza · Saxenda vs Xultophy.
- Active ingredient
- liraglutide
- Sponsor
- Novo Nordisk
- FDA applications
- NDA206321
- First FDA action
- 2014-12-23
- Most recent FDA action
- 2026-06-02
- FDA actions on file
- 20
- EU authorisation
- Saxenda
- Active trials of liraglutide
- 17
Approved indications
Quoted from the current FDA label for each application. This is what the drug is approved to treat in the US — separate from the conditions it is being studied in.
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. SAXENDA is a glucagon like peptide 1 (GLP-1) receptor agonist 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. ( 1 ) • Adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: • Coadministration with other liraglutide-containing products or with any other GLP-1 receptor agonist is not recommended. ( 1 ) • The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established. ( 1 )
FDA record
Every approved submission filed under this brand, newest first, from Drugs@FDA: original approval, efficacy supplements, labeling changes and manufacturing updates. New safety language usually arrives in a labeling supplement.
| Date | Action | Application |
|---|---|---|
| 2026-06-02 | Labeling | NDA206321 · label |
| 2026-02-25 | Labeling | NDA206321 · label |
| 2025-10-14 | Labeling | NDA206321 · label |
| 2025-05-28 | Labeling | NDA206321 · label |
| 2024-11-01 | Labeling | NDA206321 · label |
| 2023-04-20 | Labeling | NDA206321 · label |
| 2022-06-15 | Labeling | NDA206321 · label |
| 2020-12-04 | Labeling | NDA206321 · label |
| 2020-12-04 | Efficacy | NDA206321 · label |
| 2020-12-04 | Labeling | NDA206321 · label |
| 2020-03-25 | Efficacy | NDA206321 · label |
| 2018-12-04 | REMS | NDA206321 · label |
| 2018-10-19 | Efficacy | NDA206321 · label |
| 2017-05-22 | REMS | NDA206321 · label |
| 2017-04-26 | Labeling | NDA206321 · label |
| 2017-04-26 | Efficacy | NDA206321 · label |
| 2016-09-22 | Labeling | NDA206321 · label |
| 2016-02-01 | REMS | NDA206321 · label |
| 2015-03-27 | Labeling | NDA206321 · label |
| 2014-12-23 | Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated original | NDA206321 · label |
Supply records
FDA Drug Shortage Database entries naming this brand.
| Updated | Status | Presentation | FDA note |
|---|---|---|---|
| 08/25/2026 | Current | Saxenda, Injection, 6 mg/1 mL (NDC 0169-2800-15) | Product will be available until discontinuation in January 2027 |
| 08/25/2026 | To Be Discontinued | Saxenda, Injection, 6 mg/1 mL (NDC 0169-2800-15) | Product will be available until discontinuation in January 2027; Discontinuation of the manufacture of the drug |
For the molecule behind this brand — every trial, every indication under study and the full research record — see liraglutide.