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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  11/02/2010
Trade Name:  Ofirmev
Generic or Proper Name (*):  acetaminophen
Indications Studied:  Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever
Therapeutic Category:  Analgesic; Antipyretic
Ages Studied:  2 - 17 year olds
Study #:  1
Study Type:  Efficacy/Safety/Tolerability
Study Design:  Single-Blind/Active Control/Parallel Group
No Patients:  183
No Centers:  18
No Countries:  1