Benzinga | Dec 29, 2020 06:02AM EST

Amphastar Announces FDA Approval Of Abbreviated New Drug Application For Glucagon For Injection Kit, 1mg

RANCHO CUCAMONGA, Calif., Dec. 29, 2020 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved its Abbreviated New Drug Application ("ANDA") for Glucagon for Injection Emergency Kit, 1 mg. Glucagon is indicated for the treatment of severe hypoglycemia and is also used as a diagnostic aid. Amphastar's newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly's Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin.



Amphastar's CEO and President, Dr. Jack Zhang, commented: "This approval is yet another milestone for the Company and marks the first-ever FDA approval of a generic version of rDNA Glucagon. 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. This further highlights Amphastar's considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities."

According to IQVIA, the U.S. sales for Eli Lilly's Glucagon Emergency Kit for Low Blood Sugar, 1 mg, were approximately $144 million, and the 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.

Amphastar plans to launch this Glucagon for Injection Emergency Kit, which it previously referred to as AMP-001, within two months.