 Agency Supports Development of Complex Generic Drugs to Improve Competition and Access to More Affordable Medicines. Today, the U.S. 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. "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." 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... |
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