Advanced Accelerator Applications announces New Prescription Drug User Fee Act date of 26 January 2018 for Lutetium Lu 177 dotatate (Lutathera)

Advanced Accelerator Applications

28 August 2017 - Advanced Accelerator Applications today announced that the US FDA has acknowledged receipt and considered complete the resubmission of the new drug application for investigational drug lutetium Lu 177 dotatate (Lutathera). 

The Agency provided a new Prescription Drug User Fee Act date of 26 January 2018.

Read Advanced Accelerator Applications press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier