Prescription medicine
Tafamidis Brand names: Vyndamax, Vyndaqel
Tafamidis (Vyndamax) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tafamidis FDA label on DailyMed (effective May 12, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 211996 record on Drugs@FDA; every tafamidis label on DailyMed.
Highlights of the record
FDA label of May 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINDICATIONS 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.
Forms and strengths
- 20 mg
- 61 mg
Liquid-filled capsule.
On the market
- Earliest approval on file
- May 3, 2019 Vyndaqel, Foldrx Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 31, 2035 Vyndamax capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 16,240 through July 30, 2026
What is tafamidis used for?
From the label: indications and usageINDICATIONS 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.
Source: FDA drug label (Vyndaqel), NDA211996 (Foldrx Pharms), as published by Pfizer Laboratories Div Pfizer Inc, effective May 12, 2026 (SPL set 1b4121ee-a733-4456-a917-be2603477839), via openFDA; the full label on DailyMed
Is there a generic for tafamidis (Vyndamax)?
No generic tafamidis is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Vyndamax capsules: the compound patent runs to August 31, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tafamidis label say about other medicines?
The tafamidis label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name tafamidis. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Imatinib | drug interactions | Coadministration of tafamidis and drugs that are BCRP substrates may increase the exposure of substrates of this transporter (e.g., methotrexate, rosuvastatin, imatinib) and the risk of the substrate-related toxicities. |
| Methotrexate | drug interactions | Coadministration of tafamidis and drugs that are BCRP substrates may increase the exposure of substrates of this transporter (e.g., methotrexate, rosuvastatin, imatinib) and the risk of the substrate-related toxicities. |
| Rosuvastatin | drug interactions | Coadministration of tafamidis and drugs that are BCRP substrates may increase the exposure of substrates of this transporter (e.g., methotrexate, rosuvastatin, imatinib) and the risk of the substrate-related toxicities. |
Source: FDA drug label (Vyndaqel), NDA211996 (Foldrx Pharms), as published by Pfizer Laboratories Div Pfizer Inc, effective May 12, 2026 (SPL set 1b4121ee-a733-4456-a917-be2603477839), via openFDA; the full label on DailyMed
What do FAERS reports show for tafamidis?
The FDA Adverse Event Reporting System holds 16,240 reports that list tafamidis among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,821 are coded as a death and 4,611 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Tafamidis side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other