Adventrx hopes to find a new pathway for ANX-530
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Adventrx will meet with FDA April 20 to discuss the agency's refuse-to-file letter for its chemotherapy drug, ANX-530. The sponsor submitted its NDA in December 2009, but announced March 1 that FDA rejected the application because the data included in the submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. This chemistry, manufacturing and controls issue was the only reason for the RTF letter, FDA said. Adventrx is hoping to position ANX-530 as a safer therapeutic option to the currently marketed Navelbine and Taxotere
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