Victoza, Novo Nordisk's once-daily liraglutide injection, reaches the US market
The 2010 U.S. launch of Victoza gave patients with type 2 diabetes a once-daily GLP-1 injection; its boxed warning for thyroid tumors in rodents and its 0.6-to-1.8 mg dosing remain on the label today [2].
Victoza (liraglutide), a once-daily injection from Novo Nordisk, was first listed as marketed in the United States on Jan. 25, 2010, according to FDA drug listing records [1][3]. The product is approved under application number NDA 022341 and is given as a subcutaneous injection [1]. Its prescribing information lists an initial U.S. approval of 2010 [2].
What the label covers
The current label, revised in October 2025, lists two uses for Victoza [2]. It is an add-on to diet and exercise to improve blood sugar control in adults and in children aged 10 and older with type 2 diabetes, and it is used to lower the risk of major cardiovascular events — cardiovascular death, non-fatal heart attack or non-fatal stroke — in adults with type 2 diabetes and established cardiovascular disease [2]. Weight management is not among the listed indications [2].
Dosing starts at 0.6 mg injected under the skin once daily for one week, then rises to 1.2 mg once daily; if more blood sugar control is needed, the dose can go to a maximum of 1.8 mg once daily [2]. The 6 mg/mL solution comes in a prefilled, single-patient-use pen that delivers 0.6 mg, 1.2 mg or 1.8 mg [2]. Injections go in the abdomen, thigh or upper arm at any time of day, independently of meals, and injection sites should be rotated [2]. If more than three days have passed since the last dose, treatment restarts at 0.6 mg [2].
Boxed warning and side effects
Victoza carries a boxed warning about thyroid C-cell tumors [2]. Liraglutide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors in both genders of rats and mice at clinically relevant exposures, the label says, and whether it causes medullary thyroid carcinoma in humans is unknown because the human relevance of the rodent tumors has not been determined [2]. The drug is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 [2].
The most common side effects in clinical trials, reported by 5% or more of patients, were nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation [2]. The label also warns about acute pancreatitis, low blood sugar (with higher risk for those also taking insulin or an insulin secretagogue), acute kidney injury from volume depletion, severe gastrointestinal reactions — it is not recommended for people with severe gastroparesis — gallbladder disease, serious allergic reactions, and pulmonary aspiration during general anesthesia or deep sedation [2]. Pens should never be shared between patients, even if the needle is changed [2]. Victoza delays stomach emptying, which can change how oral medicines are absorbed [2].
Generics and current listings
FDA listing records also show generic liraglutide products from other manufacturers, including a Meitheal Pharmaceuticals version with a marketing start date of April 2, 2025, and a Teva Pharmaceuticals version with a marketing start date of Aug. 28, 2025 [1]. The same records list the brand Saxenda under the liraglutide name [1]. The listings do not include pricing or insurance coverage information.
Why it matters for patients
These label details are the kind patients and prescribers weigh when choosing a GLP-1 medicine. The boxed warning means a personal or family history of medullary thyroid carcinoma, or MEN 2, rules the drug out [2]. The labeled side effects are mainly digestive, and the dosing schedule starts low and steps up over weeks, which the label ties to reducing gastrointestinal reactions [2]. Low blood sugar is a specific concern for people who also take insulin or a sulfonylurea, and the label says a reduction in those doses may be necessary [2]. Victoza's approved uses are limited to type 2 diabetes, and weight management is not listed among them [2]. The label directs prescribers to counsel patients about symptoms of thyroid tumors, such as a mass in the neck, difficulty swallowing or breathing, or persistent hoarseness [2].
What happens next
Victoza's FDA listing carries a listing expiration date of Dec. 31, 2026, and Teva's generic listing carries a marketing end date of Sept. 30, 2027 [1]. Whether Novo Nordisk plans to stop marketing Victoza has not been disclosed in these records [1].
Sources
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