Amphastar Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Glucagon for Injection Emergency Kit 1mg, the first generic equivalent of Glucagon Emergency Kit (Lilly).
The generic glucagon for injection is a synthetic version of human glucagon. Glucagon is indicated for the treatment of severe hypoglycemia. It is also indicated as a diagnostic aid in the radiologic examinations of the stomach, duodenum, small bowel and colon when diminished intestinal motility would be advantageous.
The Company plans to launch Glucagon for Injection Emergency Kit within 2 months.
“Glucagon for injection has been approved for use in the US 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, PhD, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research.
For more information visit amphastar.com.
- FDA approves first generic of drug used to treat severe hypoglycemia. [press release]. Silver Spring, MD: U.S. Food and Drug Administration; December 28, 2020.
- Amphastar announces approval for Glucagon for Injection Kit, 1mg. [press release]. Rancho Cucamonga, CA: Amphastar Pharmaceuticals, Inc.: December 29, 2020.
This article originally appeared on MPR