Liraglutide
SAXENDA
SAXENDA is an FDA-approved liraglutide prescription product with a weight-management label for defined adult and pediatric populations. It is not a generic approval umbrella for every liraglutide product.
SAXENDA is one product-specific liraglutide record.
FDA's application record anchors the approved product history.
The current label defines separate adult and pediatric eligibility criteria.
The current label carries a boxed warning about thyroid C-cell tumors.
Resolve the application before the claim.
- Brand
- SAXENDA
- Active ingredient
- Liraglutide
- US application
- NDA 206321
- Company named in current label
- Novo Nordisk Inc.
- Dosage form
- Injection
- Route
- Subcutaneous
- Approval record
- SAXENDA NDA first approved in 2014
- Label record updated
- June 2026
What this approval covers - and what it does not.
This summary stays intentionally high level. Use the current full prescribing information for complete warnings, contraindications, adverse reactions, and instructions.
The exact approved record
The current US label covers chronic weight reduction and long-term maintenance in specified adults and pediatric patients age 12 years and older who meet the label's criteria.
Open current label ↗An ingredient match is not product equivalence
This record describes SAXENDA under NDA 206321. Victoza is a separate liraglutide product with a different application and label. An ingredient match alone does not establish the same approved use, presentation, or product identity.
Read the category guide →Liraglutide across 42 countries.
This record starts with the exact US FDA medicine identity. The global and state maps keep authorization, presentation, prescription route, market status, pharmacy, and seller records separate.
Compare Liraglutide by country →Compare Liraglutide by US state →The questions behind the medicine search.
Answers are based on the dated FDA and DailyMed records below. They are educational reporting, not a diagnosis, prescription, or treatment recommendation.
Are Saxenda and liraglutide the same thing?
Liraglutide is SAXENDA's active ingredient, while SAXENDA is the product reviewed under NDA 206321. Other liraglutide products can have different applications, labels, and approved uses, so the active-ingredient name is not enough to identify the correct record.
What is Saxenda FDA approved for?
The current label covers chronic weight reduction and long-term maintenance in defined adult and pediatric populations. The full prescribing information sets the exact eligibility and safety terms; this page does not assess individual suitability.
Where can I check Saxenda's approval record?
DailyMed provides the current labeling in use, and FDA's Drugs@FDA page provides the application history for NDA 206321. The direct primary-source links appear in the source ledger below.
Use the current full prescribing information and a licensed clinician or pharmacist for medicine-specific decisions. Do not substitute a research product, investigational program, or unapproved seller listing for an FDA-approved product.
Open safety and verification resources →