Determination of Regulatory Review Period for Purposes of Patent Extension; PLUVICTO
Commenting Details

Comment by Nov. 9, 2024

Posted on Sept. 9, 2024

Agency FDA

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comments last updated: September 9, 2024

In the Weeds

Document ID FDA-2023-E-2484-0005

Federal Register ID 2024-20246

Docket ID FDA-2023-E-2484

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Summary

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for PLUVICTO and is publishing this notice of that determination as required