FDA Approves First Generic of Glucagon

The first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, has been approved by the US Food and Drug Administration for the treatment of severe hypoglycemia in patients with diabetes mellitus.

The drug can also be used as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous.

The most common adverse events associated with glucagon for injection include nausea and vomiting, a temporary increase in heart rate, and redness and swelling of the injection site.

“Glucagon for injection has been approved for use in the US for more than 20 years, but until today, 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,” said Sally Choe, PhD, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research.

“Today’s approval reflects the FDA’s continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts. Supporting development and expanding opportunities to bring generic copies of complex drugs, like glucagon, to the market has been a major focus of our efforts to improve competition and help lower drug prices.”

—Amanda Balbi

Reference:

FDA approves first generic of drug used to treat severe hypoglycemia. News release. US Food and Drug Administration; December 28, 2020. Accessed December 29, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-drug-used-treat-severe-hypoglycemia