FDA Calendar Updates: FDA Panel Rejects King’s Imaging Agent

Tuesday, 28 July 2009 16:29

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 284 entries as of 7/28/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/28/09, an FDA Advisory Panel voted that King's experimental heart imaging agent, CorVue, failed to demonstrate equivalent imaging results as an older, approved agent (adenosine). In an 11-5 vote, the FDA Advisory Panel stated that the Company's study results failed to establish a high degree of similarity between images generated by CorVue and adenosine. The final FDA decision for the pending CorVue NDA is expected to occur during early 4Q09.

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