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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:  10/16/2003
 
Trade Name:  Elestat Ophthalmic Solution
 
Generic Name or Proper Name (*):  epinastine
 
Indications Studied:  Prevention of itching associated with allergic conjunctivitis in children 3 years of age and older
 
Label Changes Summary:  * Based on effectiveness and safety studies that included children down to 10 years of age * Partial waiver for children < 3 years of age because the condition does not exist in the age group * New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Allergan
 
NNPS:  FALSE
 
Therapeutic Category:  Antihistamine, topical
 
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