Radiopharmaceutical developer Navidea Biopharmaceuticals has resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its Lymphoseek radiopharmaceutical.
The resubmission follows the FDA's decision in September not to approve Navidea's initial NDA for Lymphoseek. Navidea believes that the FDA review process will involve re-evaluation of only a small portion of the NDA concerning current third-party manufacturer good manufacturing practice (GMP) compliance, and that the information it has provided will support an expeditious review.
Lymphoseek is intended to be used in lymphatic mapping procedures for staging breast cancer and melanoma, according to Navidea.
