FDA approves generic glucagon for severe hypoglycemia treatment

By Teddy Cambosa

The Food and Drug Administration has approved the use of the generic form of glucagon for treating severe hypoglycemia.

According to their online statement, FDA notes that the generic glucagon must be administered in an injection USP 1, 1mg vial packed in an emergency kit. Furthermore, 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.

She also added, “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.”

Amphastar Pharmaceuticals, Inc. of Rancho Cucamonga, California is the company being approved by the FDA for this generic glucagon for injection.

Teddy Cambosa is a graduating BS Biology student and a former campus journalist at Batangas State University. He is also currently writing for MARKETECH APAC, a small APAC-focused marketing news site.

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