FDA Approves Generic Glucagon Injection for Severe Hypoglycemia

December 29, 2020
Patrick Campbell

The US FDA announced the approval of the first generic drug for the treatment of severe hypoglycemia with the approval of the glucagon for injection USP, 1 mg/vial.

The US Food and Drug Administration (FDA) has announced the approval of the first generic drug for the treatment of severe hypoglycemia.

The US FDA announced the approval in a statement on December 28 and noted glucagon for injection USP, 1 mg/vial packaged in an emergency kit is also indicated as a diagnostic aid in the radiologic examination of the stomach.

“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, PhD, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, in a statement.

Until now, glucagon had been included on the FDA’s list of off-patent, off-exclusivity drug products without an improved generic. With approval granted to Amphastar Pharmaceuticals Inc., the approval of generic glucagon injection reflects the efforts put forth under the FDA’s Generic Drug User Fee Amendments and Drug Competition Action Plans, which was created to promote patient access and medicine affordability.

According to a statement from Amphastar Pharmaceuticals, the Glucagon for Injection Emergency Kit, 1 mg, which it previously referred to as AMP-001, was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar. Amphastar Pharmaceuticals noted they expect Glucagon for Injection Emergency Kit, 1 mg to be available within 2 months.

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

The statement from the FDA pointed out the most common side effects associated with glucagon for injection are nausea, vomiting, a temporary increase in heart rate, and redness or selling the injection site.

“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,” added Choe in the aforementioned statement. “Supporting development and expanding opportunities to bring generic copies of complex drugs, like glucagon, to the market has been a major focus of our efforts to improve competition and help lower drug prices."

This article will be updated when more information becomes available.