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Drug Information Update- FDA approves Afrezza to treat diabetes

FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.

An estimated 25.8 million (18.8 million diagnosed and 7.0 million undiagnosed) people in the United States or approximately 8.3 percent of the population–have diabetes. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage.

For more information, please visit: Afrezza.


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