FDA Approves ANDA for Glucagon Emergency Injection Kit

By Adam Hochron

The FDA has approved an Abbreviated New Drug Application for a Glucagon for Injection Emergency Kit, 1 mg. for patients with severe hypoglycemia. 

According to a release from the manufacturer, the FDA determined the product was “bioequivalent and therapeutically equivalent to another Glucagon emergency kit. 

“Using a dedicated process and sophisticated characterization technology, we demonstrated to the Agency that our highly purified synthetic product is bioequivalent and therapeutically equivalent to the reference listed drug, which is an rDNA product,” said Jack Zhang, PhD, CEO, and president of Amphastar. “This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.” 

According to the release, the company plans to launch the kit on the market within two months. 


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