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.
