MannKind confirms FDA committee vote in favor of Afrezza
Apr 1, 2014 16:55:23 GMT -5
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Post by BD on Apr 1, 2014 16:55:23 GMT -5
17:49 EDT MNKD theflyonthewall.com: MannKind confirms FDA committee vote in favor of Afrezza
MannKind announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. FDA voted 13 to 1 to recommend that Afrezza Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes. If approved, Afrezza would be the first ultra rapid-acting mealtime insulin therapy available in the United States. The FDA is not bound by the committee's recommendation but will consider its guidance in reviewing the New Drug Application that was submitted for Afrezza. The Prescription Drug User Fee Act date for the FDA to complete its review of Afrezza is April 15. :theflyonthewall.com
MannKind announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. FDA voted 13 to 1 to recommend that Afrezza Inhalation Powder be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes and voted 14 to 0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes. If approved, Afrezza would be the first ultra rapid-acting mealtime insulin therapy available in the United States. The FDA is not bound by the committee's recommendation but will consider its guidance in reviewing the New Drug Application that was submitted for Afrezza. The Prescription Drug User Fee Act date for the FDA to complete its review of Afrezza is April 15. :theflyonthewall.com