First Generic Glucagon Approved by FDA to Treat Severe Hypoglycemia

Generic Glucagon and Hypoglycemia

A significant concern for individuals with type 1 diabetes (T1D) is preventing severe hypoglycemia, also known as very low blood sugar. When blood glucose levels drop too low, it can cause confusion or lead to unconsciousness. Individuals often need someone else to administer a life-saving drug such as glucagon to raise their blood sugar back up to safer levels quickly.

Until now, only brand-name glucagon has been available for the treatment of hypoglycemia. Since it is a complex drug, it can be challenging to create safe, effective generic versions. However, generic products can be more affordable for many patients and increase competition in the market and increase drug prices.

The FDA is committed to improving access to lower-cost, high-quality generic drug products such as generic glucagon, and recently approved its production application. The drug is an injectable synthetic version of a natural hormone produced by the body to increase glucose levels. It has undergone the same testing as brand-name products to ensure that it meets the same rigorous approval standards and has comparable safety and efficacy.

The FDA has taken numerous steps to encourage pharmaceutical companies to create quality generic drug products, especially for drugs with fewer than three approved generics, including glucagon. Approval for the production of generic glucagon was given to Amphastar Pharmaceuticals, Inc. in Rancho Cucamonga, California.

The Diabetes Research Connection (DRC) is excited to see that more affordable drug products to help manage and treat type 1 diabetes are coming to market. This can help improve access to these life-saving drugs for those in need. There is not yet a cure for T1D, so reducing costs for essential medications by offering generic versions can make a difference.

The DRC is committed to funding research geared toward prevention, a cure, and improved care for individuals living with type 1 diabetes. Early-career scientists can receive funds to support novel, peer-reviewed research studies focused on any number of aspects of the disease. Learn more about some of the incredible projects taking place and find out how to help by visiting https://diabetesresearchconnection.org.

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