Lantheus Says FDA Pushed Deadline For Reviewing Its Tumor Diagnostic Kit Application

The agency is now slated to decide on the company’s application seeking approval for the diagnostic kit by June 29.

Lantheus Holdings, Inc. said on Tuesday that the U.S. Food and Drug Administration has extended its review of LNTH-2501 by three months.

The agency is now slated to decide on the company’s application seeking approval for the diagnostic kit by June 29. The extended deadline is expected to give the agency additional time to review and consider further manufacturing related information submitted by Lantheus, it said.

The extension, however, is not related to the efficacy or safety data of LNTH-2501, a radioactive diagnostic kit for detecting somatostatin receptor positive neuroendocrine tumors in adults as well as pediatric patients, the company added. 

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