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Lantheus announces three-month extension of LNTH-2501 PDUFA date

Lantheus (LNTH) announced that the FDA has extended its review of the new drug application for LNTH-2501 by three months to June 29. The extension and revised target Prescription Drug User Free Act, or PDUFA, goal date of June 29 will allow the FDA additional time to review and consider further manufacturing related information submitted by Lantheus. This standard review extension is not related to the efficacy or safety data of LNTH-2501.

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