WASHINGTON , D.C. (WDNews) — The U.S. Food and Drug Administration has approved the first generic version of Victoza (liraglutide injection), a once-daily GLP-1 receptor agonist used to manage blood sugar in patients with type 2 diabetes. The generic, produced by Hikma Pharmaceuticals USA Inc., is cleared for use in adults and children aged 10 and older as part of a diet and exercise plan.
This marks a significant milestone as GLP-1 drugs, including liraglutide, are currently in short supply. The FDA has prioritized applications for generics of these medications to improve accessibility.
“Generic drugs provide additional treatment options which are generally more affordable for patients,” said Dr. Iilun Murphy, director of the FDA’s Office of Generic Drugs.
What Liraglutide Does
Liraglutide mimics the body’s natural GLP-1 to improve blood sugar levels by enhancing pancreatic function. It addresses a critical need for those with type 2 diabetes, a condition affecting 90-95% of the 38 million Americans with diabetes, according to the CDC.
Warnings and Side Effects
The approval comes with safety precautions. Patients with a history of medullary thyroid cancer or certain endocrine conditions should avoid liraglutide. Warnings also cover risks such as pancreatitis, kidney failure, and gallbladder disease. Common side effects include nausea, vomiting, and decreased appetite.
Improving Access to Complex Medications
Generic development for complex drugs like liraglutide is challenging due to intricate formulations. The FDA is addressing these barriers through industry guidance and streamlined approval processes.
For more information on availability, contact Hikma Pharmaceuticals.
