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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:  10/25/2019
 
Trade Name:  Opana
 
Generic Name or Proper Name (*):  oxymorphone HCl
 
Indications Studied:  Postoperative pain
 
Label Changes Summary:  *Safety and effectiveness for pediatric patients, 0 to 17 years, have not been established. *An open-label study was conducted in 58 pediatric patients 12 years and older with postoperative pain. Efficacy was not demonstrated in this population treated with doses expected to be comparable to effective starting doses in adults. *Pharmacokinetic results demonstrated that treatment with Opana tablets resulted in substantially higher systemic exposures to oxymorphone in 2 out of 24 patients. *Not recommended for use in the pediatric population. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Endo
 
NNPS:  FALSE
 
Therapeutic Category:  Analgesic
 
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