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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 Change Link to Label Summary
Acyclovir Update 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 study Final Label
Approved
1/25/2019
Docket FDA-2017-N-3102
Ampicillin Revise pediatric dosing to include neonatal dosing for meningitis and septicemia based neonatal gestational age at birth and postnasal day of life.  Add seizures to adverse reactions. Final Label
Approved 2/15/2018
Docket FDA-2015-N-2342 
Lithium Add 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 Guide Final Label
Approved
10/4/2018
Docket FDA 2018-N-2986
Lorazepam Add 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
Approved
5/27/2016
Docket FDA-2015-N-3037
Meropenem for Injection Update dosing recommendations for the use of meropenem in neonates and infants less than 91 days of age for complicated intra-abdominal infections Final Label
Approved
12/19/2014
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 pressure Final Label
Approved
11/22/2013
FR Vol 79 No.16 pg 4167 Friday,
January 24, 2014