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Afrezza Approval History

  • FDA approved: Yes (First approved June 27th, 2014)
  • Brand name: Afrezza
  • Generic name: insulin human [rDNA origin]
  • Dosage form: Inhalation Powder
  • Previous name: Afresa
  • Company: MannKind Corporation
  • Treatment for: Diabetes, Type 1, Diabetes, Type 2

Afrezza (insulin human [rDNA origin]) is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.

Development History and FDA Approval Process for Afrezza

Jun 27, 2014Approval FDA Approves Afrezza to Treat Diabetes
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

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