Tuesday, December 29, 2020

FDA Approves First Generic of Glucagon - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia

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.

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, as well as redness and swelling of the injection site.

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