US FDA approves Amphastar’s generic drug to treat severe hypoglycemia

The US Food and Drug Administration (FDA) has approved the first generic drug produced by Amphastar Pharmaceuticals to treat severe hypoglycemia.

Expected to improve competition and access to more affordable medicines, the approval has been given to the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit.

The drug is produced to treat severe hypoglycemia (very low blood sugar) that could occur in patients with diabetes mellitus. The generic glucagon for injection is said to be a synthetic version of human glucagon.

Additionally, the drug is 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.

FDA 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.”

Glucagon is a hormone that causes the liver to rapidly increase blood sugar levels. It also slows down movement of the gastrointestinal tract.

Recently, FDA has accepted Hepion Pharmaceuticals’ investigational new drug (IND) application for its CRV431, a novel cyclophilin inhibitor, to treat Covid-19.