Gamma camera probe developer Neoprobe said it has completed a pre-new drug application (NDA) assessment with the U.S. Food and Drug Administration (FDA) for its Lymphoseek radiopharmaceutical agent.
Based on the assessment, the FDA has requested that data from both its completed NEO3-05 study and its in-progress NEO3-09 study be included in its primary NDA for Lymphoseek, according to the Dublin, OH-based vendor. The company had previously planned to submit the NEO3-09 data as a supplement to the primary NDA.
Neoprobe is currently enrolling patients at eight U.S. study sites for the NEO3-09 study, which is expected to be completed in the first quarter of 2011. The primary NDA is expected to be submitted soon thereafter.
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Neoprobe starts second Lymphoseek trial, May 28, 2009
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