FDA approves generic glucagon for treating severe hypoglycemia
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The FDA has approved the first generic glucagon for injection, commonly used to treat severe hypoglycemia in individuals with diabetes taking insulin, according to an agency press release.
The generic glucagon (Amphastar Pharmaceuticals Inc.) is packaged as a 1 mg vial emergency kit. In its approval, the FDA found the generic glucagon to be bioequivalent and therapeutically equivalent to Eli Lilly’s recombinant DNA (rDNA) product, according to a press release from Amphastar.
“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,” Sally Choe, PhD, director of the office of generic drugs in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”
The generic glucagon is a synthetic version of human glucagon and allows the liver to quickly increase blood glucose levels. Glucagon can also slow down movement of the gastrointestinal tract and may be used to limit intestinal motility during radiologic examinations. The most common side effects of the generic glucagon include nausea and vomiting, a temporary increase in heart rate, and redness and swelling at the injection site.
"This approval is yet another milestone for the company and marks the first-ever FDA approval of a generic version of rDNA glucagon,” Jack Zhang, CEO and president of Amphastar, said in a press release. “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, which is an rDNA product. This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities."
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