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FDA Accepts Pfizer Tafamidis Meglumine New Drug Application
Pharmaceutical Business Review -- Regulatory Affairs (02/16/12)
Pfizer's new drug application for tafamidis meglumine has been accepted by the FDA, and given a priority-review designation with an anticipated Prescription Drug Users Fee Act action date in June 2012. Tafamidis meglumine is an oral therapy for transthyretin familial amyloid polyneuropathy, a rare, progressive and fatal neurodegenerative disease that affects around 8,000 patients through the world. The drug was approved by the European Commission in Nov. 2011.
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