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Epix will resubmit imaging NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Epix Pharmaceuticals will resubmit an NDA for its novel vascular imaging agent Vasovist (gadofosveset trisodium) in mid-2008. After issuing two "approvable" letters for the agent, FDA proposed a protocol design and statistical analysis plan that could help the drug gain approval. The Lexington, Mass.-based firm said they received an action letter confirming the agreement Feb. 2...

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