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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:  10/07/2008
 
Trade Name:  Akten Ophthalmic gel 3.5%
 
Generic Name or Proper Name (*):  lidocaine hydrochloride
 
Indications Studied:  Ocular surface anesthesia during ophthalmologic procedures
 
Label Changes Summary:  * Safety and efficacy extrapolated from studies in adults and older pediatric patients using different ophthalmic formulations of lidocaine. * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Akorn
 
NNPS:  TRUE
 
Therapeutic Category:  Anesthetic, topical
 
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