Until now, people with diabetes, whose blood sugar levels were so dangerously low that they could cause confusion, blurred vision, dizziness, and even loss of consciousness, paid between $ 83 and $ 300 per episode of hypoglycemia to get out of it. The drug they use is called glucagon, a synthetic version of the natural hormone that the liver releases glucose when there is a need to raise blood sugar levels.
In late December, the FDA approved the first generic emergency glucagon kit, a 1 mg injection, for diabetic patients with severe hypoglycemia. Approved Amphastar Pharmaceuticals announced in a press release that its glucagon is the bio-equivalent of Eli Lilly’s emergency hypoglycemia kit. How much California-based Amphastar intends to charge for its kit is unknown. Amphastar also makes a generic version of adrenaline which is needed by patients with severe allergic reactions.
Diabetes patients paid these prices for decades because no generic drug was available. A generic version, according to the FDA, is difficult to replicate. However, a program approved by Congress in the early 2010s gave the FDA permission to help pharmacy companies develop difficult pharmaceutical formulas.
As part of its generic conversion program, the FDA meets with interested companies to assist them in developing these products. The FDA maintains a list of the hundreds of drugs just waiting for more competition in the market. In 2019, that list included at least 500 branded drugs.
Amphastar said the new generic would be available in two months.