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Pediatric Labeling Changes Summary Information

Pediatric Labeling Changes Resulting From BPCA and PREA through December 19, 2008

Products in this table are listed alphabetically by the trade name and fall within the scope of the Best Pharmaceuticals for Children Act (BPCA) and/or the Pediatric Research Equity Act (PREA), and contain new pediatric information. Some products appearing on this list may have had studies completed under both BPCA and PREA. All BPCA products participated in the pediatric incentive program. The PREA products which participated in the BPCA incentive program by the same sponsor are marked with an asterisk (*). The PREA products marked with a (#) are labeling changes that were not based on information from clinical trials in pediatric patients. All other labeling changes are based on information from clinical trials in pediatric patients.

†All products in this table, except biologicals with a solid dot (•) by the proper name, will have a link to labeling that reflects the labeling at the time of pediatric changes and may not be the latest labeling. Biologicals will always have a link to the most recent labeling. This list only serves to highlight key information affecting the pediatric population resulting from BPCA and/or PREA at the time that particular application was approved. For the most recent labeling please go to Drugs@FDA.

N=270 

Pediatric
Labeling
Date
Trade NameGeneric
or Proper (biologicals) Name
Indications StudiedSponsorProduct Labeling, FDA Full Reviews or Summary ReviewSummary of Labeling ChangesBPCA (B)/
PREA
(P)
10/29/2007AbilifyaripiprazoleSchizophreniaOtsukaLabel Medical Review Clinical Pharmacology Review
  • Extended schizophrenia indication from adults to adolescents 13–17 years
  • Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established
  • Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated
  • In 6-week placebo controlled efficacy trial in patients 13 – 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day
  • Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship
  • Information on dose, AEs, clinical studies
B