FDA Approves First Generic for Glucagon

Up until now, those with diabetes whose blood glucose levels sank so dangerously low that confusion, blurred vision, dizziness, even unconsciousness, could occur, 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 releases glucose from the liver when it’s necessary to raise blood glucose levels. 

  In late December, the FDA approved the first generic glucagon emergency kit, a 1mg injection, for diabetes patients experiencing severe hypoglycemia. Amphastar Pharmaceuticals, which was awarded the approval, said via a press release that its glucagon is the bioequivalent of Eli Lilly’s hypoglycemia emergency kit. Just how much Amphastar, based in California, intends to charge for its kit is unknown.  Amphastar also makes a generic version of epinephrine, needed by those experiencing severe allergic reactions.

For decades, diabetes patients paid these prices because there was no generic available. A generic version, said the FDA, was difficult to replicate. But a program approved by Congress in the early 2010s granted the FDA permission to help pharmacy companies develop difficult pharmaceutical formulas.

Through its generic conversion program, the FDA meets with interested companies to help them through the development stages of these products. The FDA keeps a list of the hundreds of drugs just waiting for more competition in the market. In 2019, that list numbered at least 500 brand drugs.

Amphastar said the new generic would be available in two months’ time. 

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