FDA Accepts New Drug Application for Neoprobe’s Lymphoseek®

Dublin-based Neoprobe announced its New Drug Application (NDA) for Lymphoseek® (tilmanocept) has been accepted for review by the U.S. Food and Drug Administration.  Neoprobe is seeking clearance to market Lymphoseek for use in Intraoperative Lymphatic Mapping (ILM), a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes.  The company is projecting FDA approval of Lymphoseek next summer.  Approval by the U.S. Food and Drug Administration would open to Neoprobe what the company has said is a $450 million market.

For more details, see the release from Neoprobe:  http://www.neoprobe.com/pressreleases/PR111019_Neoprobe_Receives_FDA_Acceptance_of_Lymphoseek_(Tilmanocept)_New_Drug_Application.pdf

Or the story from MedCity News: 
http://www.medcitynews.com/2011/10/neoprobe-name-change-to-be-announced-in-coming-weeks/