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Victoza
Victoza is a brand of liraglutide from Novo Nordisk, first approved by the FDA on 2010-01-25 under application NDA022341, authorised in the EU as Victoza, currently listed in shortage by the FDA (2 records).
Victoza is Novo Nordisk's brand of liraglutide, approved under NDA022341. The same molecule is also sold as Saxenda, 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 2026-01-30, covers cardiovascular disease, type 2 diabetes. 2 presentations are currently listed on the FDA shortage database. It is also authorised in the EU, which does not always follow the US indication wording.
Victoza and Saxenda, 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: Victoza vs Saxenda · Victoza vs Xultophy.
- Active ingredient
- liraglutide
- Sponsor
- Novo Nordisk
- FDA applications
- NDA022341
- First FDA action
- 2010-01-25
- Most recent FDA action
- 2025-10-14
- FDA actions on file
- 29
- EU authorisation
- Victoza
- 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.
Liraglutide is indicated: • as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus, • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. Limitations of Use : Liraglutide contains liraglutide. Coadministration with other liraglutide-containing products is not recommended. Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated: • as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. ( 1 ) • to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. ( 1 ) Limitations of Use : • Coadministration with other liraglutide-containing products is not recommended.
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 |
|---|---|---|
| 2025-10-14 | Labeling | NDA022341 · label |
| 2025-05-28 | Labeling | NDA022341 · label |
| 2025-02-12 | Labeling | NDA022341 · label |
| 2024-11-01 | Labeling | NDA022341 · label |
| 2023-07-05 | Labeling | NDA022341 · label |
| 2022-06-10 | Labeling | NDA022341 · label |
| 2022-06-10 | Labeling | NDA022341 · label |
| 2020-11-20 | Labeling | NDA022341 · label |
| 2020-08-05 | Labeling | NDA022341 · label |
| 2019-06-17 | Efficacy | NDA022341 · label |
| 2017-08-25 | Efficacy | NDA022341 · label |
| 2017-07-26 | REMS | NDA022341 · label |
| 2017-04-25 | Labeling | NDA022341 · label |
| 2016-09-20 | REMS | NDA022341 · label |
| 2016-04-22 | Efficacy | NDA022341 · label |
| 2015-07-01 | REMS | NDA022341 · label |
| 2015-03-09 | Labeling | NDA022341 · label |
| 2015-02-25 | Labeling | NDA022341 · label |
| 2014-07-31 | REMS | NDA022341 · label |
| 2013-06-13 | Labeling | NDA022341 · label |
| 2013-04-16 | Labeling | NDA022341 · label |
| 2012-12-13 | Labeling | NDA022341 · label |
| 2012-12-03 | Manufacturing (CMC) | NDA022341 |
| 2012-04-06 | Efficacy | NDA022341 · label |
| 2012-04-06 | Efficacy | NDA022341 · label |
| 2012-04-06 | Labeling | NDA022341 · label |
| 2011-05-18 | Labeling | NDA022341 · label |
| 2010-12-22 | Efficacy | NDA022341 · label |
| 2010-01-25 | Type 1 - New Molecular Entity original | NDA022341 · label |
Supply records
FDA Drug Shortage Database entries naming this brand.
| Updated | Status | Presentation | FDA note |
|---|---|---|---|
| 08/25/2026 | Current | Victoza, Injection, 6 mg/1 mL (NDC 0169-4060-13) | Estimated shortage duration: TBD |
| 08/17/2026 | Current | Victoza, Injection, 6 mg/1 mL (NDC 0169-4060-12) | Estimated shortage duration: TBD |
For the molecule behind this brand — every trial, every indication under study and the full research record — see liraglutide.