Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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 olderThe 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 animalsInformation on clinical study, adverse reactionsNew dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Alcon
NNPS:
FALSE'
Therapeutic Category:
Antibiotic
-
-