Label Changes for:

Ocufen (flurbiprofen sodium ophthalmic solution, USP)

July 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2012

 

 

ADVERSE REACTIONS

  • ...ocular hyperemia. Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported.
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