The FDA has approved the first generic of glucagon for injection for severe hypoglycemia, which can afflict some patients with diabetes.
FDA has also indicated glucagon to facilitate diagnosis in radiological exams of the digestive tract as the drug can reduce intestinal motility.
Glucagon is a hormone that, when released, triggers the liver to release glucose rapidly.
Last year, the agency approved Eli Lilly’s (NYSE:LLY) Baqsimi nasal powder, the first glucagon therapy indicated for the emergency treatment of severe hypoglycemia that can be administered without an injection.
Glucagon for injection has been on the market in the U.S. for more than two decades. Until recently, however, “there has been no approved generic of this important drug that can save the lives of people who may experience the serious condition of very low blood sugar,” noted Sally Choe, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research in a statement.
Chloe noted that the FDA has been working to ramp up approvals of safe and effective drugs to help curb drug prices in the U.S.
The agency maintains a list of off-patent, off-exclusivity drug products lacking approved generic equivalents.