FDA Approves Generic Glucagon Injection for Hypoglycemia

The US Food and Drug Administration (FDA) has approved the first generic of glucagon for the treatment of severe hypoglycemia in patients in patients with diabetes mellitus.

The generic of glucagon, for injection USP, 1 mg/vial packaged in an emergency kit, was authorized to Amphastar Pharmaceuticals. The FDA also indicated the product as a diagnostic tool in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be ideal.

Despite injection glucagon being a regulated therapy for hypoglycemia for the last 2 decades, there had yet to have been a generic option for the significant, at-risk patient population.

“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,” Sally Choe, PhD, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, said in a statement. “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."

The generic product is a synthetic version of human glucagon, which is a hormone known to cause the liver to rapidly increase blood sugar in the body while slowing down gastrointestinal tract movement.

Adverse events associated with injection glucagon include nausea and vomiting, a temporary heart rate increase, and injection site redness and swelling.

Via the pre-Abbreviated New Drug Application (ANDA) program, individual companies are able to meet with the FDA to facilitate complex generic drug products through the Generic Drug User Fee Amendments (GDUFA).

Along with providing guidance describing steps for generic drug product application, the FDA requires sponsors to submit appropriate data and information demonstrating generic products meet approval standards based on safety and efficacy outcomes.