FDA Receives MannKind’s Afrezza ApplicationWednesday, October 30, 2013
MannKind Corp. said Wednesday that the U.S. Food and Drug Administration has accepted its second drug application for Afrezza, an inhalable insulin powder.
The Valencia pharmaceutical company resubmitted its application to receive approval to sell Afrezza on Oct. 15. The first Afrezza application in 2009 was rejected by the FDA because it didn’t include data on a redesigned inhaler.
MannKind's latest filing includes data on the new smaller inhaler used in separate studies on patients with type 1 or type 2 diabetes. The FDA said it considered the application complete and expects to make a decision on the drug by April 15, according to a MannKind press release.
Shares closed down 31 cents, or nearly 6 percent, to $4.92 on the Nasdaq.