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The FDA has announced its approval of the first inhaled insulin product, Exubera.

Following is an excerpt of the FDA’s January 27, 2006, announcement:

There is a new, potential alternative for many of the more than 5 million Americans who take insulin injections, with the Food and Drug Administration’s approval today of the first ever inhaled insulin. Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new insulin delivery option introduced since the discovery of insulin in the 1920s.

“Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition,” said Dr. Steven Galson, Director, Center for Drug Evaluation and Research, FDA. “It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars.”

Diabetes is a disease that affects the amount of insulin and sugar in your body. Exubera is a human form of insulin and as such, lowers blood sugar concentrations by allowing the blood sugar to be taken up by cells as a source of fuel. Exubera is a powdered form of insulin that is able to be inhaled into the lungs through the patient’s mouth using a specially designed inhaler.

Click here to see the full announcement.

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