Victoza (liraglutide) reaches the US market for type 2 diabetes

Novo Nordisk's Victoza (liraglutide), a once-daily GLP-1 receptor agonist for type 2 diabetes, is listed in FDA's National Drug Code directory with a US marketing start date of January 25, 2010, under new drug application NDA 022341 ^[1][3]. The prescribing information lists an initial US approval year of 2010 ^[2].

The product is sold as an 18 mg/3 mL (6 mg/mL) clear, colorless solution in a prefilled, single-patient-use pen that delivers 0.6 mg, 1.2 mg or 1.8 mg per injection ^[2]. FDA listing records show the original Novo Nordisk package codes under NDC 0169-4060 covering cartons of one, two or three pens, with the one-pen carton flagged as a sample ^[1][3].

Dosing starts low and steps up. The label instructs adults to begin at 0.6 mg once daily, increase to 1.2 mg after one week, and go to a maximum of 1.8 mg once daily if more glucose control is needed ^[2]. The drug is injected under the skin in the abdomen, thigh or upper arm at any time of day, with or without meals ^[2]. If more than three days pass since the last dose, the label says to restart at 0.6 mg ^[2]. When used with insulin, the two must be given as separate injections and never mixed ^[2].

The boxed warning

Victoza carries a boxed warning for thyroid C-cell tumors. The label states that liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both male and female rats and mice, and that it is unknown whether the drug causes such tumors, including medullary thyroid carcinoma (MTC), in humans, because the human relevance of the rodent findings has not been determined ^[2].

Because of that, the drug is contraindicated in people with a personal or family history of MTC and in people with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) ^[2]. The label also says routine monitoring of serum calcitonin or thyroid ultrasound is of uncertain value for early detection of MTC in treated patients ^[2]. It is also contraindicated in people who have had a serious hypersensitivity reaction to liraglutide or the pen's other ingredients ^[2].

The most common side effects at 5% or higher in clinical trials were nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation ^[2]. Immunogenicity-related events including hives were reported in 0.8% of Victoza-treated patients versus 0.4% of comparator-treated patients ^[2].

Why it matters for patients

Victoza's arrival put a once-daily GLP-1 injection on US pharmacy shelves years before the weekly semaglutide products. The warnings it launched with are the same warnings that still shape how the whole GLP-1 class is prescribed today: the thyroid C-cell boxed warning and the MTC/MEN 2 contraindication appear on later drugs in the family as well.

The label also flags issues that matter in daily life. Liraglutide slows stomach emptying and may affect how other swallowed medicines are absorbed ^[2]. Pens are not to be shared between patients even if the needle is changed ^[2]. Adults taking insulin or an insulin secretagogue such as a sulfonylurea may face a higher risk of low blood sugar, and a dose reduction of those drugs may be needed ^[2].

One caveat on the date: FDA's NDC database records when a product was first listed as marketed, which is not the same as the approval date. The listing and the label agree that US availability began in 2010 ^[1][2][3].

What happens next

Later records in the same FDA database show how the molecule expanded. A higher-dose liraglutide product, Saxenda, was listed under NDA 206321 with a marketing start date of December 31, 2014 ^[1]. Generic liraglutide followed much later: Meitheal's version under ANDA 218115 lists an April 2, 2025 start, and Teva's under ANDA 214568 lists August 28, 2025 ^[1].

Victoza's label has also changed repeatedly. The version revised in October 2025 covers adults and children aged 10 and older with type 2 diabetes, plus reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease ^[2]. Recent additions include warnings on severe gastrointestinal reactions (October 2025) and pulmonary aspiration during general anesthesia or deep sedation (November 2024) ^[2].