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NIH Funded Pediatric Labeling Changes for drugs studied under the 409i process

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.

Approved Labeling Changes for Products Studied under 409i

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
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 

Add pediatric pharmacokinetic data to the Clinical Pharmacology section.

Final Labels
Bactrim Tablets Approved 7/28/2020
Bactrim Pediatric Suspension Approved 7/28/2020
Docket FDA-2018-N-3833
Caffeine Citrate Include a broader gestational age range of premature infants and longer treatment durations Final Label
Approved 3/2/2020
Docket FDA-2019-N-3414
Clindamycin Add clinical pharmacology and dosage information for obese children (clindamycin should be dosed based on total body weight) Final Labels
Cleocin Injection 3/4/2020
Cleocin Capsules 3/9/2020
Docket FDA-2019-N-4338
Clindamycin Add clinical pharmacology and dosing information for pediatric patients less than one month of age with intra-abdominal infections

Final Labels
Cleocin Phosphate 12/4/2021
Clindamycin Phosphate  9/1/2022

Docket FDA-2021-N-0142
Diazepam Update dosage and administration, clinical pharmacology data, and adverse reactions sections for patients ages 3 months to 18 years old.

Diazepam Injection 50mg/10mL, Multi-Dose Vial 11/12/21
Diazepam Injection 8/26/21
Diazepam Injection 5mg/mL 9/2/21
Diazepam Injection 5mg/mL and 10 mg/2 mL 11/12/21
Diazepam Injection 10mg/2mL 11/12/2021
Diazepam Injection 50mg/10 mL Multi-Dose Vial 8/10/2021
Diazepam Injection 5mg/mL 3/23/22
Diazepam Injection 10mg/2 mL 3/23/22
Diazepam Injection 10mg/2mL Single-Dose Prefilled Syringe 3/23/22
Diazepam Injection 5mg/mL 4/25/23

Docket FDA-2020-N-2359
Doxycycline Add pediatric data to Pharmacokinetics subsection of Clinical Pharmacology section Final Labels
Vibramycin 12/20/19
Acticlate 3/4/2020
Doryx 2/12/2020
Docket FDA-2018-N-3834
Fluconazole Update pediatric information in the Clinical Pharmacology, Clinical Studies, Precautions, Adverse Reactions, and Dosage and Administration sections including information on preterm and term infants as well as pediatric patients on extracorporeal membrane oxygenation

Approved 2/12/2024
Diflucan Oral
Diflucan IV

Docket FDA-2019-N-2698
Levetiracetam Add dosing information in Pharmacokinetics section for obese pediatric patients Final Labels
Keppra 8/31/2023
Spirtam 8/31/2023
Docket FDA-2022-N-2575
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
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
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
FR Vol 80 No. 102 pg
30467 Thursday, May 28, 2015
Rifampin Update Clinical Pharmacology and Adverse Reactions sections of the label with information for infants Rifadin capsules and Rifadin IV for injection 2/17/2023 Docket FDA-2020-N-1675
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
FR Vol 79 No.16 pg 4167 Friday,
January 24, 2014
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