FDA approves a generic form of liraglutide to treat type 2 diabetes
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Key takeaways:
- The FDA approved a generic version of liraglutide manufactured by Hikma Pharmaceuticals.
- The approval follows the launch of Teva Pharmaceuticals’ authorized generic form of liraglutide earlier in 2024.
The FDA approved a generic version of the GLP-1 receptor agonist liraglutide to improve glycemic control for people with type 2 diabetes, according to a press release from the agency.
Hikma Pharmaceuticals received approval to manufacture a generic form of Novo Nordisk’s subcutaneous liraglutide 18 mg pens (Victoza). The treatment has been approved for children and adults aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.
The approval adds to the growing list of generic GLP-1 receptor agonists on the market. As Healio previously reported, Teva Pharmaceuticals launched the first generic GLP-1 receptor agonist in June with an authorized generic of liraglutide. In November, Amneal Pharmaceuticals announced the FDA approved a generic version of AstraZeneca’s exenatide 1.2 mL and 2.4 mL pens (Byetta) as an adjunct to diet and exercise to improve glycemic control for adults with type 2 diabetes.
Liraglutide is one of several GLP-1 receptor agonists currently on the FDA’s drug shortage list. The brand-name version of the drug has been on the list since July 2023 due to demand and shipping delays, according to the FDA.
“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, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release. "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.”
Reference:
Amneal resubmits DHE autoinjector new drug application and receives U.S. FDA approval of exenatide, its first generic injectable GLP-1 agonist. Available at: https://investors.amneal.com/news/press-releases/press-release-details/2024/Amneal-Resubmits-DHE-Autoinjector-New-Drug-Application-and-Receives-U.S.-FDA-Approval-of-Exenatide-its-First-Generic-Injectable-GLP-1-Agonist/default.aspx. Published Nov. 21, 2024. Accessed Dec. 23, 2024.
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