FDA Approves First Generic Liraglutide Once-Daily Injection
By Lori Solomon HealthDay Reporter
THURSDAY, Dec. 26, 2024 -- 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."
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted December 2024
Read this next
Three Healthy Dietary Patterns Lower Incidence of Type 2 Diabetes Across Ethnicities
THURSDAY, July 31, 2025 -- Three of the most widely studied healthy dietary patterns are associated with lower incidence of type 2 diabetes (T2D), regardless of an individual's...
Prediabetes Risk Doubled for Asian, Pacific Islander Teens With Overweight, Obesity
TUESDAY, July 29, 2025 -- Among adolescents with overweight or obesity, prediabetes is more than twice as common in Asian and Pacific Islander (Asian/PI) adolescents than in White...
Glipizide Linked to Highest MACE-4 Risk in Individuals With Type 2 Diabetes
MONDAY, July 28, 2025 -- For individuals with type 2 diabetes (T2D) and moderate cardiovascular risk treated with metformin, the risk for major adverse cardiovascular events is...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.