Radiopharmaceutical developer Navidea Biopharmaceuticals was notified by the U.S. Food and Drug Administration (FDA) that the Prescription Drug User Fee Act (PDUFA) date for its Lymphoseek radiopharmaceutical has been moved to Sept. 10.
As part of its ongoing support for the Lymphoseek new drug application (NDA) review, Navidea had provided the FDA with updated chemistry, manufacturing, and control information related to one of several drug analytical assays. Since this information was submitted within the 90-day period prior to the initial PDUFA date of June 10, the FDA elected to extend the review period by 90 days to complete a first-cycle evaluation, Navidea said.
Navidea said that neither this FDA decision nor the NDA review-to-date has raised questions on Lymphoseek's safety or efficacy. The company also said that the date extension does not pertain to its ongoing head-and-neck cancer clinical trial or to the recently announced comparative analysis of Lymphoseek to sulfur colloid.
