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AVP-825 Approval Status

AVP-825 (sumatriptan) is an investigational fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine.

In November 2014, Avanir Pharmaceuticals, Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for AVP-825 (sumatriptan) had not been approved.

Development Status and FDA Approval Process 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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