Treats cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis…. NDA 211996, held by Foldrx Pharms. Tafamidis Meglumine.
As of Nov 14, 2026, NDA 211996 (Vyndaqel), held by Foldrx Pharms, was first approved by FDA on May 3, 2019, with 2 approved supplements and 0 published complete response letters.
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
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 3, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vyndaqel20MG · capsule;oral | Tafamidis Meglumine | DiscontinuedReference drug |
| Oct 17, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Jun 1, 2021 | Supplement 1Labeling · Standard review | Approved | |
| May 3, 2019 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
