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
| Date | Article |
|---|
| May 6, 2019 | Approval FDA Approves New Treatments Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) for Heart Disease Caused by Transthyretin Mediated Amyloidosis |
| Jan 14, 2019 | US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy |
| Sep 18, 2018 | New 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, 2017 | Pfizer Receives FDA Fast Track Designation for Tafamidis for Transthyretin Cardiomyopathy |
| Aug 8, 2016 | Pfizer Announces Publication of New Analysis Showing Long-Term Therapy with Vyndaqel (tafamidis) Slowed Progression of Rare Neurodegenerative Disease |
| Jun 18, 2012 | FDA Issues Complete Response Letter For Pfizer's Tafamidis Meglumine New Drug Application |
| May 25, 2012 | FDA Advisory Committee Finds Data Support Effectiveness of Tafamidis Meglumine, Pfizer's Novel Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) |
| Feb 15, 2012 | FDA Accepts Pfizer's New Drug Application for Tafamidis Meglumine, a Novel, Investigational Treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) |
| Apr 4, 2011 | Pfizer Receives Refusal To File Letter From U.S. FDA On Tafamidis New Drug Application |
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