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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  09/08/2009
 
Trade Name:  Bepreve Ophthalmic Solution
 
Generic or Proper Name (*):  bepotastine besilate
 
Indications Studied:  Ocular itching associated with allergic conjunctivitis
 
Therapeutic Category:  Antihistamine, topical
 
Ages Studied:  10 years and older
 
Study #:  1
 
Study Type:  Safety
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  127
 
No Centers:  6
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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