Neoprobe completes review for FDA app for lymph node tracing agent
Neoprobe has completed the preliminary review of information to be contained in the chemistry, manufacturing and control (CMC) module of its proposed new drug application (NDA) for Lymphoseek with the FDA.
The review of this CMC information completes the third of three planned preliminary reviews with FDA, said the Dublin, Ohio-based company. In addition, Neoprobe will be requesting a formal pre-NDA meeting to review the complete Lymphoseek regulatory package in preparation for the NDA submission.
Lymphoseek is a sentinel lymph node radioactive tracing agent undergoing phase 3 trials in breast cancer and melanoma patients. Neoprobe has an exclusive global license agreement to Lymphoseek through the University of California, San Diego.
The review of this CMC information completes the third of three planned preliminary reviews with FDA, said the Dublin, Ohio-based company. In addition, Neoprobe will be requesting a formal pre-NDA meeting to review the complete Lymphoseek regulatory package in preparation for the NDA submission.
Lymphoseek is a sentinel lymph node radioactive tracing agent undergoing phase 3 trials in breast cancer and melanoma patients. Neoprobe has an exclusive global license agreement to Lymphoseek through the University of California, San Diego.