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Treats cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis…. Sold as Vyndamax. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Tafamidis (sold as Vyndamax), first approved May 3, 2019, with 0 new uses approved and 0 published complete response letters.
First approved: May 3, 2019
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $3.92B
First approved in the EU: Nov 16, 2011
First approved in Japan: Sep 20, 2013
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 67 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Vynmac, new ingredientA drug with a new active ingredient indicated for the treatment of transthyretin cardiac amyloidosis (wild-type and hereditary). · Pfizer Japan Inc. · Sep 27, 2021
VyndaqelA drug with a new additional indication and a new dosage for the treatment of transthyretin cardiac amyloidosis (wild-type and hereditary). · Pfizer Japan Inc. · Mar 26, 2019 · Review report
Vyndaqel, new ingredientA drug with a new active ingredient indicated for delaying the peripheral neurologic impairment in transthyretin familial amyloid polyneuropathy. · Pfizer Japan Inc. · Sep 20, 2013 · Review report
Clinical Trials
13 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
