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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

Dec 14, 2017Amicus Therapeutics Submits New Drug Application to U.S. FDA for Migalastat for Treatment of Fabry Disease
Sep 19, 2017FDA Grants Fast Track Designation for Amicus Therapeutics' Migalastat for Treatment of Fabry Disease
Jul 11, 2017FDA Confirms Amicus Therapeutics May Submit New Drug Application for Migalastat for Fabry Disease
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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