The U.S. Food and Drug Administration (FDA) has approved the first generic version of Victoza (liraglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist, developed by Hikma Pharmaceuticals. The medication is used to improve glycemic control in adults and pediatric patients aged 10 and older with type 2 diabetes.
The once-daily injection (18 mg/3 mL) is intended to supplement diet and exercise, helping to address drug shortages and enhance patient access to treatment. The approval marks a significant step in providing more affordable options for diabetes care.
As reported by medicalxpress, the generic version of liraglutide carries a Boxed Warning about the increased risk of thyroid C-cell tumors. Additional warnings include risks of pancreatitis, sharing of the liraglutide pen, hypoglycemia when used with insulin or sulfonylurea drugs, renal impairment, hypersensitivity, and acute gallbladder disease.
Clinical trials have shown that the most common side effects are nausea, diarrhea, vomiting, reduced appetite, indigestion, and constipation.
Dr. Iilun Murphy, Director of the FDA Office of Generic Drugs, stated, “Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective, and high-quality generic drug products.”