The generic glucagon is a synthetic version of human glucagon, a hormone that causes the liver to increase blood sugar levels quickly
The US Food and Drug Administration (FDA) has given its approval approval for the generic glucagon for injection to Amphastar Pharmaceuticals, of Rancho Cucamonga, California.
The federal agency has granted approval for the first generic glucagon for injection USP, 1 mg/vial packed in an emergency kit for treating severe hypoglycemia, which may occur in patients with diabetes mellitus.
Severe hypoglycemia occurs when the blood sugar of a diabetes patient falls to a level where he or she becomes confused or unconscious or suffers from other symptoms. It typically occurs in diabetes patients who are on insulin treatment.
The generic glucagon for injection is a synthetic version of human glucagon. As a hormone, glucagon stimulates the liver to rapidly increase blood sugar levels.
According to the FDA, the drug is also useful as diagnostic aid in radiologic examination of the stomach, duodenum, small bowel and colon when diminished intestinal motility is advantageous.
FDA’s Center for Drug Evaluation and Research office of generic drugs director Sally Choe said: “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.
“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.”
Recently, the FDA has approved GlaxoSmithKline’s for its Benlysta (belimumab) to treat active lupus nephritis (LN) in adults, who are receiving standard therapy.