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FDA OKs first generic drug to treat severe hypoglycemia

By Brian Buntz | December 31, 2020

FDA logoThe 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.  

About The Author

Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at bbuntz@wtwhmedia.com.

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