ADVENTRX Pharmaceuticals, Inc. has announced that the FDA has accepted the proposed proprietary name “Exelbine(TM)” for the company’s product candidate ANX-530 (vinorelbine injectable emulsion).
“We are pleased with the FDA’s response to our proprietary name request and look forward to continued regulatory progress on ANX-530,” said Brian M. Culley, Chief Executive Officer of ADVENTRX.
Following completion of its review process, the FDA concluded that “Exelbine” is acceptable provided the information presented by ADVENTRX regarding the safety of interchanging ANX-530 with other vinorelbine injectable products is confirmed during review of an ANX-530 New Drug Application (NDA).
As previously announced, the Company submitted an NDA for ANX-530 to the FDA in December 2009. In March 2010, the Company announced that it had received a refusal-to-file letter from the FDA regarding its ANX-530 NDA submission. In the letter, the FDA indicated that the data included in the December 2009 NDA submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period.
The FDA identified only this one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX has requested a face-to-face meeting with the FDA to understand its requirements and define the path to a successful filing of an ANX-530 NDA at the earliest possible time.