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Label Changes for:

Cogentin (Benztropine Mesylate) Injection

April 2013

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013



Geriatric Use
  • Clinical studies of cogentin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects…