The filing is a key step for the company and has been a long time coming. If the U.S. Food and Drug Administration approves the application, Neoprobe could begin selling the drug, which would represent a huge milestone for the Dublin, Ohio-company.
The company expects an FDA decision regarding approval of the drug around the summer or fall of 2012.
Lymphoseek is a radiopharmaceutical used by surgeons to identify lymph nodes in patients with breast cancer or melanoma and to indicate whether cancer has spread to a particular lymph node.
Company officials have put its worldwide market potential at $450 million.
“This NDA submission is an important step toward improving the lives of patients who undergo lymphatic mapping procedures for potential diagnosis of the spread of solid tumor cancers,” CEO Mark Pykett said in a statement.
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