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MAY 6, 2019

FDA Approves Vyndaqel and Vyndamax for Rare Cardiac Condition

By SPC News Staff

The FDA approved tafamidis meglumine (Vyndaqel, Pfizer) and tafamidis (Vyndamax, Pfizer) capsules to treat cardiomyopathy caused by transthyretin-mediated amyloidosis (ATTR-CM) in adults. 

Vyndaqel and Vyndamax are two oral formulations of the first-in-class transthyretin stabilizer tafamidis, and the only medicines indicated for ATTR-CM. Although they have the same active moiety, tafamidis, they are not substitutable on a milligram-to-milligram basis and their recommended