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Vyndaqel FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved May 3, 2019)
Brand name: Vyndaqel
Generic name: tafamidis meglumine
Dosage form: Capsules
Company: Pfizer Inc.
Treatment for: Cardiomyopathy of Transthyretin-Mediated Amyloidosis

Vyndaqel (tafamidis meglumine) is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis.

Development timeline for Vyndaqel

May  6, 2019Approval FDA Approves New Treatments Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) for Heart Disease Caused by Transthyretin Mediated Amyloidosis
Jan 14, 2019US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy
Sep 18, 2018New Sub-group Analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) Study Presented at 2018 HFSA Annual Scientific Meeting
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

Further information

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