Levadex Approval Status

  • FDA approved: No
  • Brand name: Levadex
  • Generic name: dihydroergotamine
  • Company: MAP Pharmaceuticals, Inc.
  • Treatment for: Migraine

Levadex (dihydroergotamine) is an investigational orally inhaled migraine therapy.

FDA Approval Status 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

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