Lymphoseek tilmanocept regulatory update

FDA accepted for review an sNDA from Navidea to expand the label for Lymphoseek tilmanocept to support broader and more flexible use in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimization capabilities. The PDUFA date is Oct. 16. A separate sNDA is under Priority Review with the agency that is seeking to expand the label of Lymphoseek to include sentinel lymph node detection in patients with head and neck cancer. The PDUFA date is June 16. Navidea originally sought the label expansions in a single sNDA but said FDA chose to separate the application based on the proposed labeling extensions requested and the scope of information provided. ...