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BioWorld - Tuesday, December 16, 2025
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» FDA Delivers CRL for Pfizer's Rare Disease Drug Vyndaqel
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FDA Delivers CRL for Pfizer's Rare Disease Drug Vyndaqel
June 20, 2012
By
Karen Carey
Asking for a second efficacy study, the FDA issued a complete response letter (CRL) for Pfizer Inc.'s new drug application for tafamidis meglumine to treat the orphan indication of transthyretin familial amyloid polyneuropathy (TTR-FAP).
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