FDA Approves Generic Liraglutide for Type 2 Diabetes
As of April 2, 2025, liraglutide remained in shortage, with the drug first entering the FDA database on July 18, 2023.
The FDA approved liraglutide injection 18 mg/3 mL, a generic equivalent to liraglutide (Victoza). Meitheal Pharmaceuticals, the manufacturer of the generic medication, also announced the launch of its liraglutide injection in April 2025.1
As of April 2, 2025, liraglutide remained in shortage, with the drug first entering the FDA database on July 18, 2023. | Image Credit: Araki Illustrations - stock.adobe.com
“We are pleased to be launching and bringing liraglutide injection to market—an important option for patients with type 2 diabetes at a time when there is increased demand and limited availability for these medications,” Tom Shea, CEO of Meitheal Pharmaceuticals, said in a news release.1 “This generic provides patients with a more accessible GLP-1 treatment option, and we look forward to delivering it to our customers as quickly as possible and ensuring a sustainable, high-quality supply.”
As of April 2, 2025, liraglutide remained in shortage, with the drug first entering the FDA database on July 18, 2023. Liraglutide from Novo Nordisk currently had limited availability, with the shortage reason being either demand increase or a delay in shipping of the product.2 The approval and launch of an additional liraglutide product offers more accessibility to treatment during the time of shortage.
Liraglutide is a long-acting glucagon-like peptide-1 (GLP-1) analogue comprised of 97% amino acid homology, according to a review published in Pharmacy and Therapeutics. Receptors for GLP-1 medication are found in pancreatic cells, the central and peripheral nervous system, the heart, lungs, and gastrointestinal tract, which emphasized the use of these medications for a wide range of indications. Liraglutide promotes the secretion of insulin due to elevated glucose levels while inhibiting glucagon secretion and delaying gastric emptying, according to the authors.3
The FDA initially approved liraglutide in 2010 for the treatment of type 2 diabetes (T2D) and again in 2014 for weight loss. An additional indication was issued for pediatric patients 12 and older with obesity in 2020. It is now indicated for patients 10 years and older with T2D, improving glycemic control while reducing major cardiovascular events for patients with T2D or established cardiovascular disease.4
The most common adverse reactions for liraglutide have included nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation. The drug, like most GLP-1 medication, includes the box warning of increasing thyroid C-cell tumors, which included medullary thyroid carcinoma, due to studies in rats and mice. However, there is little data around whether this translates to humans and has not been determined. Liraglutide is contraindicated for patients with thyroid cancer or those who have a family history of it.4
Other serious adverse effects reported included acute pancreatitis, acute gallbladder disease, hypoglycemia, elevated heart rate, renal impairment, hypersensitivity reactions, and suicidal behavior and ideations.4
In treating T2D, health care professionals should be in regular collaboration, including prescribers and pharmacists. They should ensure that patients receive the medication at a reasonable cost and within the appropriate time frame to ensure patients have access to the medication and are utilizing the drug properly.4
