NIH Funded Pediatric Labeling Changes

Section 409I of the Public Health Service Act, which was created by the Best Pharmaceuticals for Children Act (BPCA), requires the National Institutes of Health (NIH), in collaboration with FDA and experts in pediatric research, to develop and publish a priority list of therapeutic areas in critical need of pediatric research. The National Institute of Child Health and Human Development (NICHD) then awards contracts to different organizations who in turn will conduct clinical trials in pediatric patients in the areas identified on the priority list. Data from these trials are to be submitted to FDA, who will determine if labeling changes are appropriate. The following table lists approved labeling changes for products studied under this program.

Product Name Labeling ChangeLink to LabelSummary
AcyclovirUpdate Dosage and Administration, Clinical Pharmacology, and Adverse Reactions sections of the label with information that dosing for neonatal HSV should be based on postmenstrual age (PMA) at doses higher than those included in the acyclovir label at the time of the studyFinal Label
Docket FDA-2017-N-3102
LithiumAdd Pediatric Use information to the Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, and Clinical Studies sections of the label, along with updates to the Medication GuideFinal Label
Docket FDA 2018-N-2986
LorazepamAdd to the Pediatric Use section, Status Epilepticus subsection, information from a randomized, double-blind, superiority-design clinical trial of Ativan versus intravenous diazepam demonstrating a failure to establish the efficacy of Ativan in the treatment of status epilepticus in pediatric patients.Final Label
Docket FDA-2015-N-3037
Meropenem for InjectionUpdate dosing recommendations for the use of meropenem in neonates and infants less than 91 days of age for complicated intra-abdominal infectionsFinal Label
FR Vol 80 No. 102 pg
30467 Thursday, May 28, 2015
Sodium Nitroprusside   Update dosing, pharmacokinetics, tolerability, and safety information in pediatric patients from birth to 18 years of age who receive SNP for controlled reduction of blood pressureFinal Label
FR Vol 79 No.16 pg 4167 Friday,
January 24, 2014


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