Generic Drug Glucagon Approved

On December 28, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus.

The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum (the first part of the small intestine beyond the stomach), small bowel and colon when diminished intestinal motility (reduced ability to move) would be advantageous.

“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, Ph.D., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research.

“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. 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.”

About Hypoglycemia

Hypoglycemia, also called low blood glucose or low blood sugar, occurs when the level of glucose in your blood drops below normal. Each person’s reaction to low blood sugar is different. From milder, more common indicators to most severe, signs and symptoms of low blood sugar include:

• Feeling shaky
• Being nervous or anxious
• Sweating, chills and clamminess
• Irritability or impatience
• Confusion
• Fast heartbeat
• Feeling lightheaded or dizzy
• Hunger
• Nausea
• Color draining from the skin (pallor)
• Feeling sleepy
• Feeling weak or having no energy
• Blurred/impaired vision
• Tingling or numbness in the lips, tongue or cheeks
• Headaches
• Coordination problems, clumsiness
• Nightmares or crying out during sleep
• Seizures

The only sure way to know whether you are experiencing low blood sugar is to check your blood sugar, if possible. If you are experiencing symptoms and you are unable to check your blood sugar for any reason, treat the hypoglycemia. A low blood sugar level triggers the release of epinephrine (adrenaline), the “fight-or-flight” hormone.

Epinephrine is what can cause the symptoms of hypoglycemia such as thumping heart, sweating, tingling and anxiety. If the blood sugar level continues to drop, the brain does not get enough glucose and stops functioning as it should.

This can lead to blurred vision, difficulty concentrating, confused thinking, slurred speech, numbness, and drowsiness. If blood sugar stays low for too long, starving the brain of glucose, it may lead to seizures, coma and very rarely death.

Glucagon

The generic glucagon for injection is a synthetic version of human glucagon. Glucagon is a hormone that causes the liver to quickly increase blood sugar levels. This hormone also slows down movement of the gastrointestinal tract. The most common side effects associated with glucagon for injection are nausea and vomiting, a temporary increase in heart rate, as well as redness and swelling of the injection site.

“The FDA regularly takes steps to help guide industry through the development process for generic drug products, including complex products such as glucagon. The development of complex products can be more difficult due to their complex active ingredient, formulation, or mode of delivery. As a result, many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval,” – the FDA reported.