FDA Approves First Generic Liraglutide Once-Daily Injection

THURSDAY, Dec. 26, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved the first generic referencing Victoza (liraglutide; Hikma Pharmaceuticals), a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes.

The approval of the once-daily injection (18 mg/3 mL), as an adjunct to diet and exercise, is intended to help with drug shortages and improve patient access.

The generic liraglutide includes a Boxed Warning to advise health care professionals and patients about the increased risk for thyroid C-cell tumors. Additional warnings include pancreatitis, liraglutide pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia like insulin and sulfonylurea, renal impairment or kidney failure, hypersensitivity, and acute gallbladder disease. Clinical trials revealed the most common side effects were nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.

“The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications,” Iilun Murphy, M.D., director of the FDA Office of Generic Drugs, said in a statement. “Today”s approval underscores the FDA”s continued commitment to advancing patient access to safe, effective, and high-quality generic drug products.”

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