| FDA Accepts Pfizer’s New Drug Application for Tafamidis Meglumine |
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16/02/2012 08:28 (96 Day 19:53 minutes ago) | |||||
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The FINANCIAL -- Pfizer Inc. announced that the U.S. Food and Drug Administration has accepted for review the New Drug Application for tafamidis meglumine, the company’s investigational, novel, oral therapy for the treatment of Transthyretin Familial Amyloid Polyneuropathy.
According to Pfizer , TTR-FAP is a rare, progressive and fatal neurodegenerative disease that affects approximately 8,000 patients worldwide.1,2,3 The European Commission approved in November 2011.
The FDA has granted the tafamidis NDA a priority-review designation and has provided an anticipated Prescription Drug User Fee Act action date in June 2012. Priority-review designation is granted to drugs that have the potential to offer significant improvement in treatment or provide a treatment where no adequate therapy exists.
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