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news.Pfizer has received negative response from the US Food and Drug Administration (FDA) for the filing of Tafamidis new drug application (NDA).
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Tafamidis is an oral experimental compound which is used to treat the patients who are suffering from Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP).
FDA said the NDA which was submitted in February 2011 was not complete to permit a substantive review.
Pfizer believes that the additional information needed to support this filing is available without further clinical studies.
Pfizer is working with the FDA to resubmit the application soon.