The FDA approved the first generic version of liraglutide (Victoza), marking the second generic glucagon-like peptide-1 (GLP-1) receptor agonist authorization.
The FDA authorized the 18 mg/3 mL injection for glycemic control in type 2 diabetes patients aged 10 years and older, as an adjunct to lifestyle modifications. Hikma Pharmaceuticals USA Inc received the approval.
The authorization maintained Victoza's safety profile, including the Boxed Warning for thyroid C-cell tumor risk. Contraindications included patients with personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome type 2, and previous serious hypersensitivity reactions.
Clinical monitoring requirements covered pancreatitis, renal impairment, hypoglycemia risk with insulin or sulfonylureas, and acute gallbladder disease. Common adverse events included nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.
The FDA's Drug Competition Action Plan facilitated this approval through regulatory guidance and research funding. The agency expedited review during the current GLP-1 shortage.
CDC data showed type 2 diabetes affected approximately 34-36 million Americans. The condition involved insulin resistance and impaired blood glucose regulation.
Liraglutide mimicked endogenous GLP-1 effects on pancreatic function. The FDA's Office of Generic Drugs Director, Iilun Murphy, MD, stated the approval demonstrated commitment to expanding complex generic medication access while maintaining safety standards.
The authorization process included manufacturing consistency and bioequivalence requirements for peptide-based therapeutics. Market availability details remained pending from the manufacturer.
Reference:
PR Newswire. FDA approves first generic of once-daily GLP-1 injection to lower blood sugar in patients with type 2 diabetes. PR Newswire. https://www.prnewswire.com/news-releases/fda-approves-first-generic-of-once-daily-glp-1-injection-to-lower-blood-sugar-in-patients-with-type-2-diabetes-302338440.html