Industry Bulletins | January 28, 2021
FDA Approves First Generic Of Drug Used To Treat Severe Hypoglycemia
The U.S. Food and Drug Administration (FDA) approved the first generic of glucagon for injection United States Pharmacopeia (USP), 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in individuals 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 FDA granted approval of this generic glucagon for injection to Amphastar . . .