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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  11/19/2010
Trade Name:  Moxeza Ophthalmic Solution
Generic Name or Proper Name (*):  moxifloxacin
Indications Studied:  Bacterial conjunctivitis
Label Changes Summary:  * Approved for use in patients 4 months and older* The safety and effectiveness have not been established in patients <4 months of age * There is no evidence that the ophthalmic administration of moxifloxacin has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals* Information on clinical study, adverse reactions* New dosage form
Product Labeling:  Labeling  Opens a new window
Sponsor:  Alcon
Therapeutic Category:  Antibiotic