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...