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FDA refuses to file Pipex’s Coprexa

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pipex believes that FDA's transfer of the NDA for Coprexa (oral tetrathiomolybdate) from the initial review division that conducted pre-NDA meetings to a new review division is the reason that the agency refused to file the application for initially-presenting neurologic Wilson's disease. The NDA was transferred to the other division in late December because a medical group in that division had expertise in diseases resulting from inborn metabolic errors. "Pipex believes that the clinical and nonclinical deficiencies cited by the FDA were already discussed, resolved and agreed upon with FDA during … pre-NDA meetings," the firm said Jan. 29 (1Pharmaceutical Approvals Monthly October 2007, In Brief). Pipex maintains the citations are substantive review issues and should be considered during review of the NDA. Pipex and FDA are scheduled to meet by the end of February to discuss the RTF decision...

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