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Navidea gets PDUFA date for Lymphoseek sNDA
The FDA sets October 16, 2014 as the target review date for Navidea Pharmaceuticals (NAVB) supplemental New Drug Application ((sNDA)) for the label expansion of Lymphoseek.
The expanded labeling will cover broader, more flexible uses in imaging and lymphatic mapping procedures, including lymphoscintigraphy and other optimization capabilities. This is the second sNDA for the product.
Lymphoseek's first sNDA pertains to its use as a sentinel lymph node detection agent in patients with head and neck cancer. The FDA granted it Fast Track designation and set a PDUFA date of June 16, 2014.
It is currently approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.
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