tafamidis meglumine

FDA Drug Profile — Vyndaqel

Drug Details

Generic Name
tafamidis meglumine
Brand Names
Vyndaqel
Application Number
NDA211996
Sponsor
Pfizer Laboratories Div Pfizer Inc
NDC Codes
1
Dosage Forms
CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients
TAFAMIDIS MEGLUMINE

Indications and Usage

1. INDICATIONS AND USAGE VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. VYNDAQEL and VYNDAMAX are transthyretin stabilizers indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. ( 1 )