Label Changes for:

Avelox (moxifloxacin) tablets and I.V.

March 2010

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010

(data numbers updated)

WARNINGS

QT prolongation
  • ...QTc prolongation occurred with moxifloxacin treatment in over 15,500 patients in controlled clinical studies, including 759...

ADVERSE REACTIONS

  • Clinical efficacy trials enrolled over 15,500 moxifloxacin orally and intravenously treated patients, of whom over 14,900 patients received the 400 mg dose.
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