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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:  04/14/2004
Trade Name:  Trusopt
Generic Name or Proper Name (*):  dorzolamide
Indications Studied:  Reduction in intraocular pressure
Label Changes Summary:  * Safety and IOP-lowering effects have been demonstrated in pediatric patients * Adverse event profile was comparable to that seen in adults
Product Labeling:  Labeling  Opens a new window
Sponsor:  Merck
Pediatric Exclusivity Granted Date:  01/05/2004
Therapeutic Category:  Ophthalmologic hypotensive