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Vyndaqel Approval Status

  • FDA approved: No
  • Brand name: Vyndaqel
  • Generic name: tafamidis meglumine
  • Company: Pfizer Inc.
  • Treatment for: Transthyretin Familial Amyloid Polyneuropathy; Transthyretin Cardiomyopathy

Vyndaqel (tafamidis meglumine) is a transthyretin (TTR) dissociation inhibitor in development for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP) and transthyretin cardiomyopathy (TTR-CM).

Development Status and FDA Approval Process for Vyndaqel

Mar 29, 2018 Pfizer Announces Positive Topline Results From Phase 3 ATTR-ACT Study Of Tafamidis In Patients With Transthyretin Cardiomyopathy
Jun  6, 2017Pfizer Receives FDA Fast Track Designation for Tafamidis for Transthyretin Cardiomyopathy
Aug  8, 2016Pfizer Announces Publication of New Analysis Showing Long-Term Therapy with Vyndaqel (tafamidis) Slowed Progression of Rare Neurodegenerative Disease
Jun 18, 2012FDA Issues Complete Response Letter For Pfizer's Tafamidis Meglumine New Drug Application
May 25, 2012FDA Advisory Committee Finds Data Support Effectiveness of Tafamidis Meglumine, Pfizer's Novel Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)
Feb 15, 2012FDA Accepts Pfizer's New Drug Application for Tafamidis Meglumine, a Novel, Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)
Apr  4, 2011Pfizer Receives Refusal To File Letter From U.S. FDA On Tafamidis New Drug Application

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