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Galafold FDA Approval History

FDA Approved: Yes (First approved August 10, 2018)
Brand name: Galafold
Generic name: migalastat
Dosage form: Capsules
Company: Amicus Therapeutics
Treatment for: Fabry Disease

Galafold (migalastat) is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant.

Development Timeline for Galafold

DateArticle
Aug 11, 2018Approval FDA Approves Galafold (migalastat) for the Treatment of Fabry Disease
Feb 12, 2018U.S. FDA Files New Drug Application Under Priority Review for Migalastat for Treatment of Fabry Disease
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

Further information

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