Medication Guide App

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).

FDA Approval Status for tafamidis

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)