FDA Approves First Generic Glucagon for Injection Kit, 1mg

Officials with the FDA have approved Amphastar Pharmaceuticals’ generic glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia, which may occur in patients with diabetes mellitus.^1,2 The first generic equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar,¹ the drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous.²

“Glucagon for injection has been approved for use in the U.S. 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, in a prepared statement.²

According to the FDA, severe hypoglycemia occurs when a patient’s blood sugar falls to a level where he or she becomes confused or unconscious, or suffers from other symptoms that require assistance from another person to treat. Typically, severe hypoglycemia occurs in people with diabetes who are using insulin treatment.²

The generic glucagon for injection is a synthetic version of human glucagon. Glucagon is a hormone that causes the liver to quickly increase blood sugar levels. This hormone also slows down movement of the gastrointestinal tract. The most common adverse effects associated with glucagon for injection are nausea and vomiting, a temporary increase in heart rate, as well as redness and swelling of the injection site.²

According to the FDA, the approval of Amphastar’s glucagon product reflects the agency’s 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,” said Choe.²

According to Amphastar, the company plans to launch its’ generic glucagon emergency kit, formerly known as AMP-001, within 2 months.¹

REFERENCES

• Amphastar Announces Approval for Glucagon for Injection Kit, 1 mg [news release]. Rancho Cucamonga, CA; December 29, 2020: Amphastar Pharmaceuticals. Accessed December 30, 2020. http://ir.amphastar.com/news-releases/news-release-details/amphastar-announces-approval-glucagon-injection-kit-1mg
• FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia [news release]. Silver Spring, MD; December 28, 2020: FDA. Accessed December 30, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-drug-used-treat-severe-hypoglycemia