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Levadex FDA Approval Status

FDA Approved: No
Brand name: Levadex
Generic name: dihydroergotamine
Dosage form: Oral Inhalation
Company: Allergan plc
Treatment for: Migraine

Levadex (dihydroergotamine) is an investigational orally inhaled ergot alkaloid intended for use in the treatment of migraine.

In April 2013, Allergan, 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 Levadex had not been approved.

Development timeline for Levadex

DateArticle
Apr 16, 2013Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Levadex (dihydroergotamine) New Drug Application
Oct 16, 2012MAP Pharmaceuticals Resubmits New Drug Application to FDA for Levadex Orally Inhaled Migraine Drug
Jun 25, 2012MAP Pharmaceuticals Provides Update Following Meeting with FDA for Levadex (dihydroergotamine) New Drug Application
Apr 12, 2012MAP Pharmaceuticals Provides Update on Levadex Program
Mar 26, 2012MAP Pharmaceuticals Receives Complete Response Letter from FDA for Levadex (dihydroergotamine) NDA
Aug 11, 2011MAP Pharmaceuticals Issued U.S. Patent for Methods of Achieving Rapid Relief of Migraine and Minimizing Side Effects Based Upon Pharmacokinetic Profile
Aug  2, 2011MAP Pharmaceuticals Announces FDA Acceptance for Filing of NDA for Levadex
May 27, 2011MAP Pharmaceuticals Submits New Drug Application to FDA for Levadex Orally Inhaled Migraine Drug
Jan 11, 2010MAP Pharmaceuticals Announces FDA Will Not Require a Second Pivotal Efficacy Study for Levadex NDA Submission

Further information

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