Label Changes for:
Avelox (moxifloxacin hydrochloride in NaCl injection) I.V.
April 2009
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. |
| Brand (Generic) Name |
Sections Modified |
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Avelox (moxifloxacin hydrochloride) Tablets Avelox (moxifloxacin hydrochloride in NaCl injection) I.V. Label approved 04/27/2009 is not available on Drugs@FDA |
MEDICATION GUIDE “new safety information” with the use of Avelox, particularly the increased risks of tendonitis and tendon rupture.
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