Generic for Common Hypoglycemia Rx Approved

FDA approves first generic of glucagon for injection to treat hypoglycemia

(RxWiki News) The US Food and Drug Administration (FDA) has approved a generic version of an injected drug used to treat very low blood sugar.

The FDA approved the glucagon for injection USP, 1 mg/vial packaged in an emergency kit, to treat severe hypoglycemia (very low blood sugar). Typically, this condition occurs in people who have diabetes who are using insulin treatment.

The brand name version of this medication has been approved in the United States for more than two decades. Now, patients may have a cheaper option through the newly approved generic version.

"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,” said Dr. Sally Choe, director of the FDA's Office of Generic Drugs, in a press release.

People who have diabetes often use insulin to keep their blood sugar levels from getting too high (hyperglycemia). Sometimes, however, blood sugar levels can fall to dangerously low levels as a result of diabetes treatments like this. Very low blood sugar can cause blood sugar drops so low that they are unable to treat it themselves. Very low blood sugar can cause confusion or a loss of consciousness, and it can be fatal.

Glucagon is a hormone that causes blood sugar levels to increase rapidly. This newly approved generic is a synthetic version of this human-derived hormone meant to raise blood sugar levels when they fall to potentially dangerous levels.

Glucagon is also used in radiologic exams of the stomach, intestines and bowels. This drug slows down the movement of the gastrointestinal tract, the FDA noted.

Common side effects of injected glucagon include redness and swelling of the injection site, nausea and vomiting and a temporary increase in heart rate.

The FDA approved generic glucagon for Amphastar Pharmaceuticals, Inc.

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Review Date: 
January 8, 2021