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Some brand companies have attempted to generate second stays by filing new listings and new suits on new ANDAs from the same generic, but courts scrutinize this as a potential abuse of the stay mechanism

At 2.5mg/mL, the same dose would require 100 units, the entire capacity of a standard 1 mL insulin syringe

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The safety considerations around peptide medications are serious, and unregulated products carry real risks including contamination, incorrect dosing, and lack of sterility

FDA criticized the company for not establishing and maintaining procedures to validate the device design