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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Alcon Research, Ltd.
NNPS:
TRUE
Therapeutic Category:
Antibiotic, topical
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