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Latest NewsDecember 29, 2024 FDA Approves Generic GLP-1 For Treatment of Type 2 Diabetes The Food and Drug Administration (FDA) approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, 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 as an adjunct to diet and exercise. Liraglutide injection and certain other GLP-1 medications are currently in shortage. Liraglutide improves blood sugar levels by creating similar effects in the body as GLP-1 in the pancreas, which is often found in insufficient levels in type 2 diabetes patients. According to the Centers for Disease Control and Prevention, more than 38 million Americans have diabetes, and 90% to 95% of those individuals have type 2 diabetes. The prescribing information for the generic liraglutide injection approved includes a Boxed Warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. Liraglutide also carries warnings about pancreatitis, liraglutide pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia including insulin and sulfonylurea, renal impairment or kidney failure, hypersensitivity and acute gallbladder disease. The most common side effects reported in the clinical trials for liraglutide injection include nausea, diarrhea, vomiting, decreased appetite, dyspepsia and constipation. The FDA granted the approval of generic liraglutide injection to Hikma Pharmaceuticals USA Inc. [FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes. FDA 23 Dec 2024.]
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