US FDA approves first generic glucagon injection to treat severe hypoglycaemia

The US Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus. The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum (the first part of the small intestine beyond the stomach), small bowel and colon when diminished intestinal motility (reduced ability to move) would be advantageous. The FDA granted approval of this generic glucagon for injection to Amphastar Pharmaceuticals of Rancho Cucamonga, California.

“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, Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research.

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.

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 the movement of the gastrointestinal tract. The most common side 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.