• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

  • Print
  • Share
  • E-mail
-

N = 500
n = 453 with New Pediatric Studies; n = 47 with No New Pediatric Studies
BPCA only = 157; BPCA + PREA = 66; PREA only = 228; Rule = 48; None = 1

Pediatric Labeling Changes as of September 30, 2013

This list highlights key pediatric information from the studies submitted in response to pediatric legislative initiatives. CBER regulated products have an asterisk (*) by the proper name. To obtain all the information for a pediatric labeling change, select the pediatric labeling date in the first column of the database to reveal the additional information. To view all records in the database, select the All button at the bottom of the page. To search for a specific pediatric labeling change, enter the trade name or generic name in the Filter box and select Show Items. Note: CBER and CDER regulated biologics with pediatric labeling changes before 9/27/2007 are excluded from the database.
Download New Pediatric Labeling Information Database data in Microsoft Excel web format  Click on this link to download all data from the selected searchable database in Excel format. If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players .



Advanced Search

   No. of Records Found:  500
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
02/03/2006 ProAir HFA Inhalation Aerosol albuterol Prevention of exercise-induced bronchospasm in children 12 years of age and older * Expands use from previously approved bronchospasm with reversible obstructive airway disease * Effectiveness based on study in adults and adolescents * Safety and effectiveness in pediatric patients below 12 years of age have not been established * New indication Antiasthmatic
02/01/2006 Clarinex-D 12 Hour Extended Release Tablets desloratadine/pseudoephedrine Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis in children 12 years of age and older * Approval based on two safety and effectiveness studies in patients down to 12 years of age * Not an appropriate dosage form for use in pediatric patients below 12 years of age. * Studies waived in children < 12 years of age * New dosing regimen Antihistamine
12/21/2005 TamiFlu oseltamivir Prophylaxis in pediatric patients 1 year to <13 years of age * Information on postmarketing clinical study in patients 1 to 12 years Antiviral
12/21/2005 Fosamax alendronate Severe osteogenesis imperfecta * Alendronate is not indicated for use in children * The efficacy and safety were examined in a randomized, double-blind, placebo-controlled two-year study of 139 patients, 4-18 years old, with severe osteogenesis imperfecta * Treatment with alendronate did not reduce the risk of fracture * There were no statistically significant differences between the alendronate and placebo groups in reduction of bone pain * Information on PK parameters, AE profile, and clinical studies Bone density
12/08/2005 Meridia sibutramine Obesity * The data are inadequate to recommend the use of sibutramine for the treatment of obesity in pediatric patients * Efficacy in obese adolescents has not been adequately studied * Sibutramine's mechanism of action inhibiting the reuptake of serotonin and norepinephrine is similar to that of some antidepressants * It is unknown if sibutramine increases the risk of suicidal behavior or thinking in pediatric patients * In a study of adolescents with obesity in which 368 patients were treated with sibutramine and 130 patients with placebo, one patient in each group attempted suicide. Suicidal ideation was reported by 2 sibutramine-treated patients and none of the placebo patients Obesity management
12/01/2005 Effexor XR Extended-Release Capsules venlafaxine Social anxiety disorder * Provided additional safety data for changes in weight, height, and appetite occurring in pediatric patient * Information based on a clinical study of patients with SAD * New indication (not approved in pediatric patients) Antidepressant
11/28/2005 Amaryl glimepiride Type-2 Diabetes Mellitus * Data are insufficient to recommend pediatric use of glimepiride * In an active-controlled, single-blind, 24-week trial, 272 pediatric patients aged 8 to 17 years with Type 2 diabetes were randomized to treatment with glimepiride or metformin. Trial suggested differences favoring metformin * AE profile in the pediatric population was similar to that for adults * Information on PK parameters Antidiabetic
11/09/2005 Fluocinolone Acetonide Oil fluocinolone Chronic eczematous external otitis (outer ear) in children 2 years of age and older * Effectiveness established in studies of patients 2 years of age and older * New indication Anti-inflammatory, topical
10/28/2005 Trileptal oxcarbazepine Use as adjunctive therapy in children aged 2 years and above with epilepsy * Extended adjunctive therapy age range from 4 years down to 2 years * No evidence drug was effective as adjunctive therapy in patients < 2 years * In clinical studies as adjunctive therapy, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the dose per body weight compared to adults; and children 4 to d12 years of age may require a 50% higher dose per body weight compared to adults * Approximately 11% of pediatric patients < 4 years discontinued treatment because of adverse events including convulsions, status epilepticus and ataxia * Information on dose, PK parameters, AE profile and clinical studies Neurology        
10/19/2005 Levemir insulin detemir [rDNA origin] injection Type 1 diabetes Summary is pending Antidiabetic
10/06/2005 Norvir ritonavir Treatment of HIV-infection in combination with other antiretroviral agents * Extended age range from 2 years down to 1 month * AE profile in the pediatric population was similar to that for adults * Information on dose and PK parameters Antiviral
09/28/2005 Emtriva emtricitabine HIV-1 infection in combination with other antiretroviral agents * Safety and effectiveness in pediatric patients 3 months and older supported by data from 3 open-label, nonrandomized clinical studies * Safety and effectiveness in patients < 3 months have not been established * Relative bioavailability of Emtriva oral solution is approximately 80% of Emtriva capsules. Thus, maximum dosage is different for these 2 formulations: Solution max - 240 mg once daily; Capsules max - children weighing > 33 kg one 200 mg capsule once daily * The AE profile in pediatric patients was comparable to that observed in adults * Information on dose, PK parameters, AE profile and clinical studies * Antiviral
09/13/2005 NovoLog insulin aspart recombinant injection Diabetes Mellitus * In clinical studies comparing NovoLog to regular human insulin in patients 2 to 18 years with type 1 diabetes, NovoLog achieved glycemic control comparable to regular human insulin * The incidence of hypoglycemia was similar for both treatment groups Antidiabetic
08/11/2005 Mobic meloxicam Relief of signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis * Safety and efficacy established in patients 2 years of age and older * Clinical studies evaluated doses ranging from 0.125 mg/kg/day to 0.375 mg/kg/day. There was no additional benefit demonstrated by doses above 0.125 mg/kg/day in the clinical trials. The lowest effective dose should be used * Adverse events in children were similar to those in adults including skin reactions and gastrointestinal bleed risk * Information on dose, PK parameters, AE profile and clinical studies Anti-inflammatory
08/04/2005 Loperamide Hydrochloride Soft Gelatin Capsules loperamide Control symptoms of diarrhea in children 12 years of age and older * New dosage form; new dosing regimen * No new clinical studies * Bioequivalence study in adults compared the current OTC drug (Imodium caplet) and this drug * Studies waived in children 0-2 years of age Antidiarrheal
07/29/2005 Avandia rosiglitazone Type 2 Diabetes Mellitus * Data are insufficient to recommend pediatric use of rosiglitazone * In a 24 week double-blind controlled trial in children with type 2 diabetes mellitus, aged 10 to 17 years, with a baseline BMI of 33 kg/m2 were randomized to treatment with rosiglitazone or metformin * Mean change from baseline in HbA1c was -0.14% with rosiglitazone and -0.49% with metformin * There was an insufficient number of patients to establish statistically whether these observed mean treatment effects were similar or different * Weight gain similar to that in adults * Information on PK parameters, and AE profile Antidiabetic
07/27/2005 Singulair Oral Granules, Tablets, and Chewable Tablets montelukast Relief of symptoms of perennial allergic rhinitis in children 6 months of age and older *Effectiveness was extrapolated from a allergic rhinitis study in patients 15 years of age and older * Safety in patients 6 to 23 months is supported by data from PK and safety and efficacy studies in asthma in this pediatric population and from adult PK studies * Studies waived in children < 6 months of age * New indication Antiasthmatic; antiallergy
07/21/2005 Adderall XR amphetamines mixed salts ADHD * Expanded labeling for 13-17 year olds * On a mg/kg body weight basis children 6-12 years have a higher clearance than adolescents or adults. Body weight is the primary determinant * There was not adequate evidence that doses greater than 20 mg/day conferred additional benefit in a placebo-controlled study conducted in adolescents aged 13-17 with ADHD * In a single-dose PK study in adolescents, isolated increases in systolic blood pressure (SBP) were observed in patients receiving 10 mg and 20 mg Adderall XR. Higher single doses were associated with a greater increase in SBP * Sustained increases in blood pressure should be treated with dose reduction and/or appropriate medication * Information on dose, PK parameters, and AE profile CNS Stimulant
06/29/2005 Topamax Tablets and Sprinkle Capsules topiramate Initial monotherapy for partial onset or primary generalized tonic-clonic seizures in children 10 years of age and older * Effectiveness established in studies of patients down to 6 years of age * Use in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials * Provides information regarding treatment-emergent decrease in serum bicarbonate and adverse events * Some patients in the study discontinued therapy due to adverse events; however, adverse events associated with discontinuing therapy included difficulty with concentration/attention * Studies waived in children 0-2 years of age; deferred in children 2-10 years of age * New indication Anticonvulsant
06/21/2005 Keppra levetiracetam Adjunctive therapy in the treatment of partial onset seizures in patients with epilepsy * Extended indication from adults to patients 4 years and older * Safety and effectiveness have not been established in patients less than 4 years of age * PK analysis showed that clearance increased with an increase in body weight * Approximately 22% increase of apparent total body clearance of levetiracetam when co-administered with enzyme-inducing Anti-Epileptic Drugs (AEDs). Dose adjustment not necessary * 37.6% of pediatric patients reported behavioral symptoms compared to 13.3% in adults * Somnolence occurred in 22.8% in pediatric patients compared to 14.8% in adults * Information on dose, PK parameters, AE profile and clinical studies Anticonvulsant
05/26/2005 Focalin XR Extended-Release Capsules dexmethylphenidate Treatment of Attention-Deficit Hyperactivity Disorder in children 6 years of age and older * Should not be used in children under 6 years of age * Effectiveness in patients age 6 years of age and older was established in clinical studies * PK studies also conducted * Long-term effects in children have not been established * New dosage form CNS Stimulant
05/25/2005 Merrem I.V. meropenem Treatment of complicated skin and skin structure infections in children 3 months of age and older * Supported by extrapolating safety and effectiveness from an adequate and well-controlled adult study and additional data from pediatric PK studies * Studies waived for children < 3 months of age * New indication Antibiotic
05/18/2005 Invanz ertapenem Complicated Intra-abdominal Infections; Complicated Skin and Skin Structure Infections; Community Acquired Pneumonia; Complicated Urinary Tract Infections; Acute Pelvic Infections * Approved for use down to 3 months of age. Efficacy extrapolated from studies in adults and supported by PK and safety studies in pediatric patients * Not recommended in infants under 3 months of age as no data are available * Not recommended in the treatment of meningitis in the pediatric population due to lack of sufficient CSF penetration * Information on dose, PK parameters, AE profile and clinical studies Antibiotic
05/13/2005 Ortho Tri-Cyclen norgestimate/ ethinyl estradiol Evaluation of total hip bone mineral density in adolescent females with anorexia nervosa * No significant difference between Ortho Tri-Cyclen and placebo in mean change in total lumbar spine (L1-L4) and total hip bone mineral density in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year clinical trial Contraceptive
05/12/2005 Zyvox linezolid Central nervous system infections * PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF * Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended * Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium Antibiotic
05/06/2005 Doryx Delayed-Release Tablets doxycycline Treatment of infections * No new clinical studies submitted * PK data * Dosing information for new dosage form (to decrease esophagitis seen from capsules) * New dosage form Antibiotic
04/26/2005 Gemzar gemcitabine Refractory leukemia * Effectiveness in pediatric patients has not been demonstrated * Phase 1 trial in pediatric patients with refractory leukemia demonstrated a maximum tolerated dose; however, no meaningful clinical activity observed in a Phase 2 trial of gemcitabine in 22 patients with relapsed acute lymphoblastic leukemia and 10 patients with acute myelogenous leukemia * Toxicities observed were similar to those reported in adults Antineoplastic
03/25/2005 Zofran ondansetron Prevention of chemotherapy-induced and postoperative induced nausea and vomiting * Established dosing for surgical patients down to 1 month from 2 years of age * Established dosing for cancer patients down to 6 months from 4 years of age * Surgical and cancer patients < 18 years tend to have a higher ondansetron clearance compared to adults leading to a shorter half-life in most pediatric patients * The clearance of ondansetron in patients 1- 4 months of age is slower and the half-life is approximately 2.5 fold longer than patients who are > 4  24 months of age * Patients < 4 months of age receiving this drug should be closely monitored * Additional information on dose, PK parameters, AE profile and safety Antiemetic
03/11/2005 Rapamune sirolimus Prophylaxis of organ rejection in patients undergoing renal transplants * Safety and efficacy established in children 13 years or older judged to be at low to moderate immunologic risk * Safety was assessed in a controlled clinical trial in pediatric (<18 years of age) renal transplant recipients considered high immunologic risk. The use of Rapamune in combination with calcineurin inhibitors and corticosteroids was associated with an increased risk of deterioration of renal function, lipid abnormalities, and urinary tract infections * Safety and efficacy have not been established in pediatric patients less than 13 years old or in pediatric renal transplant recipients considered at high immunologic risk * Information on PK parameters, adverse events and safety Immunosuppressant
03/11/2005 Xopenex HFA Inhalation Aerosol levalbuterol Treatment of bronchospasm in patients with reversible obstructive airway disease in children 4 years of age and older * Extended indication for use in children down from 6 years of age * Pediatric patients have a lower exposure to the drug than adults * Population PK model developed from patients down to 4 years of age * Effectiveness and safety established from studies in adults, adolescents (12 years of age and older) and children ages 4-11 years of age with asthma. * Deferred studies in patients < 4 years of age * New active ingredient Antiasthmatic
03/03/2005 Clarinex D 24 Hour Extended Release Tablets desloratadine/pseudoephedrine Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in patients 12 years of age and older * Two safety and effectiveness studies conducted in patients 12 years of age and older * PK study * Studies waived in children < 12 years of age * New active ingredient; new dosing regimen Antihistamine
02/18/2005 Celexa citalopram Major Depressive Disorder * Safety and effectiveness in the pediatric population have not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Celexa or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Celexa is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * Two placebo-controlled trials in 407 pediatric patients with MDD have been conducted with Celexa, and the data were not sufficient to support a claim for use in pediatric patients Antidepressant
02/18/2005 Zoloft sertraline Major Depressive Disorder and Obsessive Compulsive Disorder * Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents * Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings and Precautions: Pediatric Use) Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * Two placebo controlled trials in 373 pediatric patients with MDD have been conducted with Zoloft, and the data were not sufficient to support a claim for use in pediatric patients Antidepressant
01/12/2005 Paxil paroxetine Major Depressive Disorder * Safety and effectiveness in the pediatric population have not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Paxil or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Paxil is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * Three placebo-controlled trials in 752 pediatric patients with MDD have been conducted with Paxil, and the data were not sufficient to support a claim for use in pediatric patients Antidepressant
01/12/2005 Remeron mirtazapine Major Depressive Disorder * Safety and effectiveness in the pediatric population have not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Remeron or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Remeron is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with Remeron and the data were not sufficient to support a claim for use in pediatric patients Antidepressant
01/12/2005 Serzone nefazodone Major Depressive Disorder * Safety and effectiveness in the pediatric population have not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Serzone or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Serzone is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * Two placebo-controlled trials in 286 pediatric patients with MDD have been conducted with Serzone, and the data were not sufficient to support a claim for use in pediatric patients Antidepressant
12/28/2004 Clolar clofarabine Relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens * Labeling for patients 1 to 21 years old. This use is based on the induction of complete responses * Randomized trials demonstrating increased survival or other clinical benefit have not been conducted * Information on dose, PK parameters, and AE profihe Antineoplastic
12/22/2004 Pataday Ophthalmic Solution olopatadine Treatment of ocular itching associated with allergic conjunctivitis (itchy eyes) in children 3 years of age and older * Based on clinical trials that included patients down to 3 years of age. * New indication Antihistamine, topical
12/17/2004 Augmentin ES-600 Powder for Oral Suspension amoxicillin; clavulanate Treatment of acute bacterial sinusitis (ABS) (sinus infection) in children 3 months of age and older * No new pediatric studies * Effectiveness extrapolated from adult studies for Augmentin XR for ABS and from studies in pediatric patients with otitis media and by similar pharmacokinetics in pediatric patients * New indication Antibiotic
12/16/2004 VisionBlue Ophthalmic Solution trypan blue Aid in ophthalmic surgery by staining anterior capsule * Approved for use in all populations based on information from clinical trials in the literature * New drug Ophthalmologic stain
12/10/2004 Agrylin anagrelide Myeloproliferative disorders * An open-label study evaluated PK/PD but not efficacy. * Information on PK/PD profile, dosing, AEs, and safety in patients > 6 years to 17 years * No overall difference in dosing and safety were observed between pediatric and adult patients * Established recommended starting dose based on limited data. Dosage should be adjusted to the lowest effective dosage Hematology/Coagulation
11/16/2004 Zomig zolmitriptan Migraine * Clinical trial evaluating zolmitriptan in pediatric patients ages 12 -17 years did not establish the safety and effectiveness when compared to placebo * AEs observed in clinical trials were similar to those observed in clinical trials in adults. Antimigraine
10/21/2004 Concerta methylphenidate ADHD * Expanded labeling for 13-17 year olds including information on dose, PK parameters, and AE profile * Increase in age resulted in increased apparent oral clearance * For patients new to methylphenidate: higher maximum recommended dosage for adolescents compared to children 6-12 years of age * Data are inadequate to determine whether chronic use of stimulants in children may cause suppression of growth. Therefore, growth should be monitored during treatment * Safety and efficacy in children <6 years have not been established CNS Stimulant
10/13/2004 Imitrex Nasal Spray sumatriptan Migraine * Five clinical trials evaluating oral sumatriptan in pediatric patients ages 12 -17 years did not establish the safety and effectiveness when compared to placebo * Postmarketing experience documents that serious AEs rarely reported in adults, including stroke, visual loss, and death have occurred in the pediatric population after use of subcutaneous, oral, and/ or nasal sumatriptan. * Since clinical data to determine the frequency of serious adverse events in pediatric patients who might receive injectable, oral, and/ or intranasal sumatriptan are not presently available, the use of sumatriptan in patients aged younger than 18 years is not recommended Antimigraine
09/29/2004 Amlexanox Mucoadhesive Patch amlexanox Treatment of apthous ulcers in children 12 years of age and older * Approval based on monograph and previous studies for other indication * No new studies submitted * Studies in children birth  12 years of age waived * New indication Anti-inflammatory, topical
09/01/2004 Clarinex desloratadine Seasonal and perennial allergic rhinitis, and the symptomatic relief of pruritus, and hives * Indicated for seasonal allergic rhinitis down to 2 years of age. Extended age range down to 6 months for perennial allergic rhinitis and chronic idiopathic urticaria * Safety and effectiveness of tablets or syrup has not been established in pediatric patients less than 6 months of age * Information on dose, PK parameters, and AE profile in pediatric patients 6 months - 11 years of age Antihistamine
08/19/2004 Vioxx rofecoxib Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis * Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004. Anti-inflammatory
08/13/2004 Ferrlecit sodium ferric gluconate complex Iron deficiency anemia in chronic hemodialysis patients receiving supplemental erythropoietin therapy * Safety and effectiveness established in pediatric patients 6 -15 years old * Patients <6 years of age not studied * Information on dose, PK parameters and AE profile Vitamin
07/30/2004 Claritin-D 12 Hour Extended-Release Tablets Claritin-D 24 Hour Extended-Release Tablets loratadine; pseudoephedrine Temporary relief of nasal congestion due to the common cold in children 12 years of age and older OTC * Approval based on monograph and previous studies for other indication * No new studies submitted * Studies in children birth - 12 years of age waived * New indication Antihistamine
06/24/2004 Camptosar irinotecan Refractory solid tumors * Effectiveness in pediatric patients has not been established * Adverse event profile from a Phase 2 trial with 170 children with refractory solid tumors comparable to that seen in adults; Grade 3-4 neutropenia experienced by 54 (31.8%) patients, neutropenia complicated by fever in 15 (8.8%) patients, Grade 3-4 diarrhea observed in 35 (20.6%) patients. * Accrual for phase 2 study with 21 children with previously untreated rhabdomyosarcoma halted due to high rate (23.6%) of progressive disease and early deaths (14%) * Adverse event profile seen in the 21 children different than that observed in adults; most significant Grade 3 or 4 adverse events were dehydration experienced by 6 patients (28.6%) associated with severe hypokalemia in 5 patients (23.8%) and hyponatremia in 3 patients (14.3%); in addition Grade 3-4 infection was reported in 5 patients (23.8%)(across all courses of therapy and irrespective of causal relationship) * PK parameters comparable to adults * Minimal accumulation of irinotecan and SN-38 (active metabolite) observed in children on daily dosing Antineoplastic

Prev  |  Next  |  5  |  6  |  [7]  |  8  |  9  |  First  |  Last  |  All

Products in this table are listed by labeling change date in descending order and fell within the scope of the Pediatric Rule, the Best Pharmaceuticals for Children Act (BPCA), and the Pediatric Research Equity Act (PREA), and contain new pediatric information. All other labeling changes are based on information from clinical trials in pediatric patients. This list only serves to highlight key information affecting the pediatric population at the time the particular application was approved resulting from the studies performed for the Pediatric Rule, BPCA and PREA.

Helpful Links:
Drug and therapeutic biological labeling:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Biological labeling and reviews:
http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122938.htm

BPCA 2002 Review Summaries:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm161894.htm

**The Protopam labeling change is an exception. The labeling change is included in the Pediatric Labeling Changes Table even though it was not triggered by BPCA or PREA.

-
-