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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