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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
 
PREA(P):  P
 
Sponsor:  Alcon
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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