ADVENTRX Pharmaceuticals, Inc. will meet the FDA in Washington D.C. during the last week of April 2010 to review the company's New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion) and the FDA's refusal-to-file letter.
ADVENTRX had 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.
"We look forward to meeting with the agency next month to clarify the necessary steps for filing the ANX-530 NDA this year," said Brian M. Culley, Chief Executive Officer of ADVENTRX.
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.