NIH Funded Pediatric Labeling Changes

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

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