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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: tafamidis meglumine
Trade Name: VYNDAQEL; VYNDAMAX
Date Designated: 02/17/2012
Orphan Designation: Treatment of symptomatic transthyretin (TTR) amyloid cardiomyopathy.
Orphan Designation Status: Designated/Approved
FoldRx Pharmaceuticals, Inc., a subsidiary of Pfizer Inc.
445 Eastern Point Road
Groton, Connecticut 06340
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: tafamidis meglumine
Trade Name: VYNDAQEL; VYNDAMAX
Marketing Approval Date: 05/03/2019
Approved Labeled Indication: 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.
Exclusivity End Date: 05/03/2026 
Exclusivity Protected Indication* :  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.

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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