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Tafamidis Approval Status

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

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

In June 2012, Pfizer Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for tafamidis had not been approved.

Development Status and FDA Approval Process for tafamidis

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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