The US Food and Drug Administration (FDA) announced on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycaemic control.
The product from Hikma Pharmaceuticals USA Inc, a subsidiary of Hikma Pharmaceuticals plc (LON:HIK), is for adults and children aged 10 years and older with type 2 diabetes, to work alongside diet and exercise.
With the approval of a generic referencing Byetta (exenatide), the FDA approved the first generic in this class of medications last month.
There is currently a shortage of liraglutide injection and certain other GLP-1 medications. The FDA prioritises evaluation of generic drug applications for drugs in shortage to help improve patient access.
Iilun Murphy, MD, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, said: "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. Generic drugs provide additional treatment options which are generally more affordable for patients. 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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