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Migalastat Approval Status

  • FDA approved: No
  • Generic name: migalastat
  • Company: Amicus Therapeutics
  • Treatment for: Fabry Disease

Migalastat (AT1001) is an investigational pharmacological chaperone in development for the treatment of Fabry disease.

Development Status and FDA Approval Process for migalastat

DateArticle
Nov 28, 2016Amicus Therapeutics Announces U.S. Regulatory Pathway for Migalastat for Fabry Disease
Sep 15, 2015Amicus Therapeutics Plans to Submit NDA for Migalastat for Fabry Disease Following Positive Pre-NDA Meeting With FDA

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