FDA clears first generic for treatment for severe hypoglycemia

FDA approved the first generic version of an emergency kit to treat low blood sugar. The result could be competition for Eli Lilly and other pharma companies that have dominated the market with their brand-name products.

FDA granted the approval of glucagon for injection USP 1 mg/vial, packaged in an emergency, kit to Amphastar Pharmaceuticals to treat severe hypoglycemia, which may occur in patients with diabetes mellitus.

Related: FDA clears first ready-to-use insulin for IV injection

The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel and colon when diminished intestinal motility would be advantageous, FDA said in a press release.

Sally Choe

“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. “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.”

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Overall U.S. sales of brand products containing glucagon for injection, 1 mg, were approximately $306 million for the 12 months ended September 30, 2020, according to IQVIA, while sales for Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, 1 mg, were approximately $144 million for the same time period, Amphastar said in a press release.

Jack Zhang

“Using a dedicated process and sophisticated characterization technology, we demonstrated to the Agency that our highly purified synthetic peptide product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), which is an rDNA product,” Amphastar CEO and President Jack Zhang, said.

Amphastar plans to have the glucagon emergency kit available within two months.

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