First Generic of Glucagon for Injection Approved

December 29, 2020 – The U.S. FDA has approved Amphastar Pharmaceuticals’ generic glucagon for injection USP, 1mg/vial packaged in an emergency kit. It is the first generic version of glucagon for injection.

Branded glucagon first received FDA approval more than 20 years ago. Glucagon is indicated to treat hypoglycemia (very low blood sugar) and 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 a temporary reduction in intestinal motility is advantageous for imaging.

Glucagon is a hormone produced naturally by the body that triggers an increase in blood sugar levels and slows the movement of the gastrointestinal tract. Amphastar’s generic is a synthetic version of this hormone that is administered as a subcutaneous or intramuscular injection. Recommended dosing is based on the indication as well as individual patient factors including weight, age, and treatment response.

Amphastar has launched the generic at a wholesale acquisition cost (WAC) of $280 per kit, which is equivalent to the WAC for brand name glucagon.