ADVENTRX Pharmaceuticals, Inc. today announced that, based on information received from the FDA, the company plans to resubmit its New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion), or Exelbine(TM), in the fourth quarter of 2010.
"We are pleased to have clarified with the FDA certain matters concerning the stability data necessary to file the Exelbine NDA," said Brian M. Culley, Chief Executive Officer of ADVENTRX. "The studies that will generate the stability data from our intended commercial manufacturing site that the FDA wishes to see are ongoing, and we plan to resubmit the NDA in the fourth quarter of this year." ADVENTRX submitted an NDA for ANX-530 to the FDA in December 2009. The Company announced on March 1, 2010 that it had received a refusal-to-file letter from the FDA regarding that 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. No clinical or nonclinical issues were identified.