Safe and Effective Medicines for Children Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (2012) / Chapter Skim
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Appendix D: Biologics Studied and Not Studied in Children
Appendix D: Biologics Studied and Not Studied in Children
Pages 321-380
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between January 1, 1997, and December 31, 2010. FDA supplied the list of biologics for products now regulated by the Center for Drug Evaluation and Research (CDER)
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FDA waived the requirement for pediatric studies because the product 1 The original approval dates and marketing status for biologics are not always easily de termined. It is possible that one or more of the products listed had an original approval date prior to 1997.
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. For the biologics including in the committee's more extensive investigation, the committee consulted the current product labeling for references to pediatric studies; examined approval letters, if available, for references to required pediatric studies; checked FDA's tracking database for postmarket study requirements and commitments for required studies; and searched ClinicalTrials.gov.
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The database was checked from July to December 2011. The brief summaries in the trials database were sometimes incorrect in indicating that a trial included children, particularly when the more detailed trial descriptions did not include an overview description of the age range but did make clear in the inclusion or exclusion criteria that only adults were eligible.
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(BLA Number) Highlights of Pediatric Information Original Approval Date Approved Indication(s)
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Highlights of Pediatric Information Original Approval Date Approved Indication(s) in Labeling 3.
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(BLA Number) Ages of Trial Trial Original Approval Date Condition Participants Phase 1.
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Ages of Trial Trial Original Approval Date Condition Participants Phase 3. Adalimumab Juvenile rheumatoid arthritis 4 to 17 yr III (Humira)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 7. Alglucosidase alfa Pompe disease (late onset)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 12. Bevacizumab Solid tumors Up to 21 yr I (Avastin)
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Ages of Trial Trial Original Approval Date Condition Participants Phase ≥2 yr 13. Canakinumab Cryopyrin-associated periodic III (Ilaris)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 17. Daclizumab Immune suppression in kidney Up to 21 yr (Zenapax)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 23. Eculizumab Hemoglobinuria 2 to 17 yr I/II (Soliris)
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Ages of Trial Trial Original Approval Date Condition Participants Phase ≥5 yr 28. Idursulfase Hunter syndrome n/s ≥5 yr (Elaprase)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 33. Interferon gamma-1B Osteopetrosis 2 mo to 10 yr III (Actimmune)
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Ages of Trial Trial Original Approval Date Condition Participants Phase ≥ 6 yr or 37. Omalizumab Asthma, multiple trials for moderate III, ≥12 yr (Xolair)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 40. Palivizumab Respiratory syncytial virus infection Up to 2 yr (Synagis)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 45. Peginterferon alfa-2B Neurofibromatosis 18 mo to II (Pegintron)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 51. Rituximab Leukemia; lymphoma Six trials (Rituxan)
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(BLA Number) Ages of Trial Trial Original Approval Date Condition Participants Phase 1.
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Ages of Trial Trial Original Approval Date Condition Participants Phase 3. Alpha1-proteinase Type 1 diabetes mellitus 10 to 25 yr I/II inhibitor (human)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 9. Anti-thymocyte Transplant-related complications, Various age I, II, globulin (rabbit)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 15. Coagulation factor IX Hemophilia B (multiple studies)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 22. Fibrinogen Cardiac surgical procedures Up to 18 yr II ≥6 yr concentrate (human)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 28. Immune globulin injection (human)
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Ages of Trial Trial Original Approval Date Condition Participants Phase 34.
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Ages of Trial Trial Original Approval Date Condition Participants Phase ≥6 yr 39. von Willebrand Bleeding prevention in surgery III factor/coagulation Von Willebrand disease n/s n/s factor VIII complex Hemophilia A Any age n/s (human)
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