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Pipelineliraglutide › Victoza

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 NDA022341
label effective 2026-01-30 · full label

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.

DateActionApplication
2025-10-14LabelingNDA022341 · label
2025-05-28LabelingNDA022341 · label
2025-02-12LabelingNDA022341 · label
2024-11-01LabelingNDA022341 · label
2023-07-05LabelingNDA022341 · label
2022-06-10LabelingNDA022341 · label
2022-06-10LabelingNDA022341 · label
2020-11-20LabelingNDA022341 · label
2020-08-05LabelingNDA022341 · label
2019-06-17EfficacyNDA022341 · label
2017-08-25EfficacyNDA022341 · label
2017-07-26REMSNDA022341 · label
2017-04-25LabelingNDA022341 · label
2016-09-20REMSNDA022341 · label
2016-04-22EfficacyNDA022341 · label
2015-07-01REMSNDA022341 · label
2015-03-09LabelingNDA022341 · label
2015-02-25LabelingNDA022341 · label
2014-07-31REMSNDA022341 · label
2013-06-13LabelingNDA022341 · label
2013-04-16LabelingNDA022341 · label
2012-12-13LabelingNDA022341 · label
2012-12-03Manufacturing (CMC)NDA022341
2012-04-06EfficacyNDA022341 · label
2012-04-06EfficacyNDA022341 · label
2012-04-06LabelingNDA022341 · label
2011-05-18LabelingNDA022341 · label
2010-12-22EfficacyNDA022341 · label
2010-01-25Type 1 - New Molecular Entity originalNDA022341 · label

Supply records

FDA Drug Shortage Database entries naming this brand.

UpdatedStatusPresentationFDA note
08/25/2026CurrentVictoza, Injection, 6 mg/1 mL (NDC 0169-4060-13)Estimated shortage duration: TBD
08/17/2026CurrentVictoza, 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.