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AVP-825 Approval Status

  • FDA approved: No
  • Brand name: AVP-825
  • Generic name: sumatriptan
  • Company: Avanir Pharmaceuticals, Inc.
  • Treatment for: Migraine

AVP-825 (sumatriptan) is an investigational fast-acting, dry-powder intranasal form of sumatriptan in development for the treatment of migraine. In November 2014, the FDA issued a Complete Response Letter for AVP-825 NDA.

FDA Approval Status for AVP-825

Nov 26, 2014Avanir Pharmaceuticals Receives Complete Response Letter (CRL) from FDA on AVP-825 NDA
Nov  7, 2014Avanir Pharmaceuticals Announces Preliminary Feedback from the FDA on AVP-825 for the Acute Treatment of Migraine
Oct 30, 2014Avanir Pharmaceuticals Announces Publication of Pivotal Phase III Results from AVP-825 Acute Migraine Study
Mar 26, 2014Avanir Pharmaceuticals Announces Acceptance of NDA for AVP-825 for the Acute Treatment of Migraine
Jan 30, 2014Avanir Pharmaceuticals Announces Submission of New Drug Application for AVP-825 for the Acute Treatment of Migraine

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