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Vyndaqel Approval Status

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

Vyndaqel (tafamidis meglumine) is a transthyretin (TTR) dissociation inhibitor under investigation for the treatment of patients with Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP).

Development Status and FDA Approval Process for Vyndaqel

DateArticle
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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