FDA Approves First Generic Glucagon for Injection

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

The Food and Drug Administration has granted approval of this generic glucagon for injection to Amphastar Pharmaceuticals, Inc. of Rancho Cucamonga, Calif.

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 side effects associated with glucagon for injection are:

• Nausea and vomiting
• A temporary increase in heart rate
• Redness and swelling of the injection site

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.

"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, Ph.D., 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."

Addressing the challenges related to complex generics, and promoting more generic competition to these medicines, is a key part of the FDA's Drug Competition Action Plan, and the agency's efforts to promote patient access and more affordable medicines.