UPDATE 1-US FDA declines Lantheus’ tumor imaging kit over third-party manufacturing issues

Lantheus Holdings Inc

Lantheus Holdings Inc

LNTH

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June 26 (Reuters) - The U.S. Food and Drug Administration declined to approve Lantheus Holdings’ LNTH.O diagnostic imaging kit for types of cancer tumors citing unresolved manufacturing-related conditions at a third-party facility, the company said on Friday.

This marks another setback for the company, as the FDA in March extended its review of the imaging kit, LNTH-2501, by three months.

The FDA did not identify any concerns regarding the data submitted by Lantheus in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501, said the company.





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