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 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 |
| Bactrim | 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 Monodox 5/8/2024 | 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 |
| Furosemide | Update to the Pharmacokinetics subsection of the Clinical Pharmacology section to include pediatric data | Final Labels Approved 10/1/2024 Furosemide Injection (American Regent) Furosemide Injection (Pfizer) Furosemide Injection (Fresenius Kabi) Furosemide Injection (Hikma) | Docket FDA-2023-N-4781 |
| 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 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 |
| Metronidazole | Add information on the pharmacokinetics, dosing, safety, and effectiveness of metronidazole in pediatric patients from birth to less than 4 months of age with intra-abdominal infections | Final Labels Metronidazole Injection (Baxter) 3/14/2025 Metronidazole Injection (Hospira) 3/14/2025 Metronidazole Injection (B. Braun) 3/14/2025 | Docket FDA-2023-N-3160 |
| Oxcarbazepine | Add data for pediatric patients with obesity to the Pharmacokinetics subsection of the Clinical Pharmacology section | Final Labels Oxtellar XR 8/14/2024 Trileptal 9/4/2024 | Docket FDA-2023-N-3161 |
| Oxycodone | Add information from lactation studies regarding potential effects on breastfed infants to the Lactation section | Approved 4/19/2024 Percodan (aspirin and oxycodone) tablets Roxicodone (oxycodone hydrochloride) tablets oxycodone hydrochloride capsules oxycodone hydrochloride oral solution oxycodone hydrochloride oral solution Oxaydo (oxycodone hydrochloride) tablets RoxyBond (oxycodone hydrochloride) tablets | FDA-2023-N-3159 |
| 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 Approved 11/22/2013 | FR Vol 79 No.16 pg 4167 Friday, January 24, 2014 |
| Topiramate | Add information for pediatric patients with obesity to the Pharmacokinetics subsection of the Clinical Pharmacology section | Final Labels Trokendi XR Capsules 3/10/2025 Topamax Tables and Capsules 3/12/2025 Qudexy XR Capsules 3/12/2025 | Docket FDA-2024-N-1986 |