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Afrezza Approval Status beta

  • FDA approved: No
  • Brand name: Afrezza
  • Generic name: insulin human [rDNA origin]
  • Previous name: Afresa
  • Company: MannKind Corporation
  • Treatment for: Diabetes, Type 1, Diabetes, Type 2

Afrezza (insulin human [rDNA origin]) Inhalation Powder is an ultra rapid-acting insulin for oral inhalation in development for the treatment of adults with type 1 or type 2 diabetes mellitus.

FDA Approval Status for Afrezza

DateArticle
Apr  7, 2014MannKind Updates Status of New Drug Application for Afrezza
Apr  2, 2014FDA Advisory Committee Recommends Approval of Afrezza - Investigational Drug to Treat Diabetes
Oct 14, 2013MannKind Resubmits New Drug Application to U.S. FDA for Afrezza for the Treatment of Adults with Diabetes
Aug 14, 2013MannKind Reports Positive Data from a Phase 3 Clinical Study of Afrezza in Patients with Type 1 Diabetes
Aug 12, 2011MannKind Confirms Design of Pivotal Studies for Afrezza
Jan 20, 2011MannKind Corporation Receives Complete Response Letter from the FDA for Afrezza
Dec 28, 2010MannKind Updates Status of New Drug Application for Afrezza
Jul 20, 2010FDA Accepts Afrezza Complete Response Resubmission and Sets Target Action Date
Mar 15, 2010FDA Requests Additional Information Regarding Afrezza in Complete Response Letter to MannKind
Jan 13, 2010MannKind Updates Status of Afrezza New Drug Application
May 21, 2009Emisphere Technologies Receives Milestone Payment from MannKind Corporation
Mar 16, 2009MannKind Submits NDA for Afresa for Treatment of Diabetes

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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