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FDA decision regarding MannKind delayed

Posted: April 7, 2014 5:05 p.m.
Updated: April 7, 2014 5:05 p.m.

MannKind Corp. of Santa Clarita announced Monday that the U.S. Food and Drug Administration has extended by three months the review period of its ultra-rapid-acting diabetes treatment.

Review of Afrezza, a powder inhaled through a device the size of a whistle, was pushed back to July 15 by the FDA.
Inhaling the powder delivers the insulin treatment to the bloodstream within 12 to 15 minutes, compared to 90-150 minutes required for insulin injections.

Just last week an advisory panel to the FDA recommended approval of Afrezza, saying the biomedical company had clearly demonstrated its effectiveness.

But some members of the panel expressed concerns about possible side effects, including the affect the drug would have on the lungs.

Originally, the FDA decision had been expected around April 15.




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