Saxenda Regulatory Status: Approvals in the US, EU, Canada, and UK

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Is Saxenda approved in the United States?

Yes. The FDA approved Saxenda under NDA 206321 on 23 December 2014 [1]. It is a once-daily subcutaneous injection of liraglutide; the recommended adult dose is 3 mg daily, reached in weekly steps from 0.6 mg, and lower doses are for titration only [1].

The current label, effective 25 February 2026, covers weight reduction and long-term weight maintenance alongside a reduced-calorie diet and more physical activity in adults and pediatric patients aged 12 and older with body weight above 60 kg and obesity, and in adults with overweight plus at least one weight-related comorbid condition [1]. For adults, the label says to discontinue if at least 4% of baseline body weight has not been lost by 16 weeks, or if the 3 mg dose cannot be tolerated [1]. It also says Saxenda should not be combined with other liraglutide-containing products or any other GLP-1 receptor agonist [1].

Generic liraglutide is FDA-approved [3]. Generics referencing Saxenda include Teva (ANDA 214568), Biocon (ANDA 217063) and Cipla (ANDA 217234) [3].

Is Saxenda authorised in the European Union?

Yes. The EMA lists Saxenda as authorised for use in the European Union [2]. The EU product information covers adults with obesity (BMI 30 or more); adults with overweight (BMI 27 to 30) and weight-related complications such as diabetes, high blood fat, high blood pressure or obstructive sleep apnoea; adolescents from 12 years with obesity who weigh more than 60 kg; and children from 6 to under 12 years with obesity (BMI at or above the 95th percentile) who weigh at least 45 kg [2].

The EU product information sets a stopping rule: after 12 weeks at the maximum or maximum tolerated dose, treatment should be stopped when weight loss is below 5% for adults or below 4% for children and adolescents, and the need to continue should be reassessed once a year [2].

Did the US safety warnings change?

On one item, yes. The FDA asked on 13 January 2026 that the makers of Saxenda, Wegovy and Zepbound remove the suicidal behavior and ideation language from their labels, after a review it says found no increased risk with GLP-1 receptor agonist medications [4]. The Saxenda label effective 25 February 2026 has no such section [1]; the version dated 26 January 2024 did, with instructions to monitor for depression or suicidal thoughts and to discontinue if symptoms developed [5].

Saxenda carries a boxed warning about thyroid C-cell tumours in rats and mice, with human relevance unknown, and is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with MEN 2 [1]. Pregnancy is not in the current contraindications list; the label says to discontinue Saxenda when pregnancy is recognised [1].