Radiopharmaceutical developer Navidea Biopharmaceuticals intends to file a marketing authorization application (MAA) in Europe for Lymphoseek, a kit for the preparation of technetium Tc 99m for injection, the company said.
Navidea has begun preparations to submit an MAA to the European Medicines Agency for Lymphoseek by the end of this year, according to the firm. The process is similar in scope to the company's new drug application submission to the U.S. Food and Drug Administration in August 2011.
Navidea will seek clearance to market Lymphoseek for use in intraoperative lymphatic mapping and in lymphoscintigraphy imaging procedures, the company said.
