Navidea (NAVB) Gets 90-Day PDUFA Extension on Lymphoseek

April 3, 2012 9:02 AM EDT
Navidea Biopharmaceuticals, Inc. (AMEX: NAVB) announced that yesterday it received notification from the United States Food and Drug Administration (FDA) that the Prescription Drug User Fee Act (PDUFA) date for 99m-Tc-Tilmanocept (Lymphoseek®), has been modified to September 10, 2012, a 90-day extension from the initial PDUFA date of June 10th. Lymphoseek is an investigational, proprietary radioactive tracing agent for lymphatic mapping and lymphoscintigraphy.

As part of its ongoing support of the Lymphoseek NDA review, on March 30, 2012, the Company provided as requested by the Agency, updated chemistry, manufacturing and control information related to one of several drug analytical assays. As this information was submitted within the 90-day period prior to the PDUFA date, on April 2nd, FDA at its option elected to extend the review period by 90 days to complete a first-cycle evaluation. Neither this FDA decision nor the NDA review-to-date has raised questions on Lymphoseek’s safety or efficacy. The PDUFA date extension does not pertain to the Company’s ongoing head and neck cancer clinical trial or to the recently announced comparative analysis of Lymphoseek to sulfur colloid.

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