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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:  02/29/2016
 
Trade Name:  Tetracaine Hydrochloride Ophthalmic Solution
 
Generic Name or Proper Name (*):  tetracaine hydrochloride
 
Indications Studied:  For use in procedures requiring a rapid and short-acting topical ophthalmic anesthetic
 
Label Changes Summary:  * Approved for use in adults and pediatric patients. * Safety in the pediatric population has been demonstrated in clinical trials. Efficacy for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population. * Information on dosing. * New drug.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Alcon Research, Ltd.
 
NNPS:  TRUE
 
Therapeutic Category:  Antibiotic, topical
 
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