The U.S. Food and Drug Administration (FDA) has elected not to approve radiopharmaceutical developer Navidea Biopharmaceuticals' new drug application (NDA) for its Lymphoseek radiopharmaceutical.
In a letter to Navidea, the FDA noted the decision was focused on issues with third-party contract manufacturing of Lymphoseek, and was not related to any efficacy or safety data filed within the NDA, according to Navidea.
Navidea president and CEO Mark Pykett, PhD, said the company is working closely with the FDA and its third-party contract manufacturers to address all requirements to support the shortest possible NDA resubmission and review.
Lymphoseek is intended to be used in lymphatic mapping procedures for staging of breast cancer and melanoma.
