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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 523
n = 474 with New Pediatric Studies; n = 49 with No New Pediatric Studies
BPCA only = 158; BPCA + PREA = 70; PREA only = 244; Rule = 50; None = 1

Pediatric Labeling Changes as of July 15, 2014

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 .



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   No. of Records Found:  523
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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
06/24/2004 TamiFlu oseltamivir Treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older * Not recommended in pediatric patients less than 1 year of age because of uncertainties regarding the rate of development of the human blood-brain barrier and the unknown clinical significance of animal toxicology data for human infants Antiviral
06/21/2004 Codeprex Extended-Release Suspension chlorpheniramine; codeine Temporary relief of cough associated with the common cold or inhaled irritants; temporary relief of symptoms of hay fever, other upper respiratory allergies, or allergic rhinitis in children 6 years of age and older OTC * Approval and age range based on monograph for antitussives and antihistamine * No clinical studies submitted * Studies in children < 6 years of age deferred * New dosage form; new dosing regimen Antihistamine
06/17/2004 Prevacid lansoprazole Short-term treatment of symptomatic GERD and erosive Esophagitis * Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age * Safety and effectiveness in pediatric patients <1 year of age have not been established * Information on dose, PK parameters, and AE profile Antiulcerative
06/02/2004 Humalog Injection insulin lispro Treatment of patients with diabetes mellitus for the control of hyperglycemia (high blood sugar) in children 3-11 years of age * Safety and effectiveness established from studies in patients 3-11 years of age * Dosing information added for external insulin pumps * New route of administration Antidiabetic
05/25/2004 Axid nizatidine Esophagitis, and heartburn due to GERD * Indicated in pediatric patients 12 years and older * Information on dose, PK parameters, and AE profile Antiulcerative
05/06/2004 Lidosite Topical System Kit epinephrine; lidocaine Topical local analgesia for superficial dermatological procedures in children 5 years of age and older * 505(b)(2) with clinical studies * Safety and effectiveness established in studies of pediatric patients 5-18 years of age * PK study in pediatric patients 6-15 years of age dosing regimen established in clinical trials * Studies in patients 0-5 years of age deferred * New dosage form; new route of administration Anesthetic, topical
05/05/2004 Effexor and Effexor XR venlafaxine Major Depressive Disorder * Effectiveness in pediatric patients has 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 Effexor 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. Effexor 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. * 18% of Effexor XR treated patients (6-17 years) versus 3.6 % of placebo treated patients experienced a weight loss of at least 3.5 % in both MDD and the GAD studies * In an open-label study increases in weight were less than expected based on data from age and sex matched peers. The difference between observed weight gain was larger for children less than 12 years than for adolescents older than 12 years * During an 8 week placebo controlled GAD trial, Effexor XR treated patients ages 6-17 years grew an average of 0.3 cm, while placebo treated patients grew an average of 1 cm. In a 6 month open-label study, height increases that were less than expected based on data from age and sex matched pairs. The difference between observed and expected growth rates were larger for children less than 12 years than for adolescents older than 12 years * Decreased appetite observed in 10% of patients ages 6-17 years old receiving Effexor XR * Occurrence of blood pressure and cholesterol increases considered clinically relevant in pediatric patients similar to that observed in adults Antidepressant
04/29/2004 Mucinex DM Extended-release Tablet guaifenesin; dextromethorphan Expectorant and cough suppressant in children 12 years of age and older * 505(b)(2) approved with no pediatric information * Age range based on monograph * Do not use in children under 12 years of age * studies waived in children < 12 years of age due to safety concerns * New dosage form Cough suppressant
04/21/2004 Advair Diskus fluticasone/ salmeterol Asthma * Extended indication from 12 years down to 4 years of age Antiasthmatic
04/14/2004 Detrol LA tolterodine Urinary frequency and urge incontinence due to neurogenic conditions * Efficacy in pediatric population has not been demonstrated * The dose-plasma concentration relationship is linear in patients from 11 to 15 years * Parent/ metabolite ratios differed according to CYP2D6 metabolizer status * 710 pediatric patients ages 5 -10 years with urinary frequency and urge incontinence were studied in 2 randomized placebo controlled trials. Urinary tract infections were higher in patients treated with Detrol LA (6.6%) compared to placebo (4.5%) * Aggressive, abnormal and hyperactive behavior and attention disorders occurred in 2.9% of children treated with Detrol LA compared to 0.9% treated with placebo Urology
04/14/2004 Trusopt dorzolamide Reduction in intraocular pressure * Safety and IOP-lowering effects have been demonstrated in pediatric patients * Adverse event profile was comparable to that seen in adults Ophthalmologic hypotensive
04/01/2004 Corlopam fenoldopam Indicated for the in-hospital, short-term reduction in blood pressure * Indicated for the in-hospital, short-term (up to 4 hours) reduction in blood pressure in pediatric patients <1 month (at least 2 kg) to 12 years of age * Information on PK, dose and AE profile * Clinical studies did not include patients 12  16 years of age Antihypertensive
03/31/2004 Zemplar paricalcitol Secondary hyperparathyroidism associated with end stage renal disease * Safety and effectiveness were examined in a 12 week randomized, double-blind, placebo-controlled study of 29 pediatric patients aged 5-19 years old with end stage renal disease on hemodialysis; information * Primary efficacy analysis revealed 9 of 15 patients in Zemplar group had 2 consecutive 30 % decreases from baseline intact PTH compared with 3 of 14 patients in placebo group * No patients in either group developed hypercalcemia (defined as at least one calcium value >11.2 mg/dL) during study Vitamin D analog
03/25/2004 Cipro ciprofloxacin Complicated UTI and pyelonephritis * Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1  17 years of age * Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues * Information on PK and dose in pediatric patients 1  17 years of age * The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively Antibiotic
03/19/2004 Viracept nelfinavir HIV-1 * Safety and effectiveness established in patients 2  13 years of age * New twice daily dosing regimen and modified three times daily dosing for pediatric patients > 2 years * A reliably effective dose not established in patients <2 years of age * PK information in pediatric patients from birth to 13 years of age * Highly variable drug exposure is a significant problem in pediatric patients * Adverse event profile was similar to that for adults Antiviral
03/15/2004 Glucovance glyburide/ metformin Type 2 Diabetes Mellitus * As studied in active-controlled, double blind trial in pediatric patients (9  16 years of age), Glucovance was not statistically superior to either metformin or glyburide in reducing HbA1C from baseline * No unexpected safety findings Antidiabetic
03/11/2004 Cozaar losartan Hypertension * Antihypertensive effects established in hypertensive patients 6-16 years of age * Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/ min/1.73 m2 due to no data * Information on PK and dose in pediatric patients 6-16 years of age. * No relevant differences between the AE profile for pediatric patients compared to reported AEs for adults * Information on preparation of a suspension Antihypertensive
03/08/2004 Ultiva remifentanil Maintenance of anesthesia * Safety and efficacy for the maintenance of anesthesia established from birth to 1 year of age * Recommended dosing guidelines for maintenance of anesthesia for patients from birth to 2 months * The clearance rate observed in neonates was highly variable  approximately 2 times higher than young healthy adults * Individual doses for each patient should be carefully titrated Anesthetic agent
03/05/2004 Arava leflunomide Polyarticular Juvenile Rheumatoid Arthritis * Safety and efficacy in pediatric patients with polyarticular JRA have not been fully evaluated * 94 patients with polyarticular JRA were studied in a double-blind active controlled trial (1:1 randomization); approximately 68% of pediatric patients receiving Arava versus 89% receiving active comparator demonstrated improvement on the primary endpoint by week 16 * Pediatric patients with a body weight d 40 kg have a reduced clearance relative to adult rheumatoid arthritis patients * Information on PK of M1, the active metabolite responsible for in vivo activity in children 3-17 years old * Most common adverse events in 74 polyarticular JRA patients 3-17 years old included abdominal pain, diarrhea, nausea, vomiting, oral ulcers, upper respiratory tract infections, alopecia, rash, headache, and dizziness * 14 of the 74 patients experienced ALT and/or AST elevations; 5/14 were between 3 and 8 fold the upper limit of normal Anti-inflammatory
03/02/2004 Lotensin benazepril Hypertension * Information on dose, PK in pediatric patients 6-16 years of age * Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/min/1.73 m2 due to insufficient data * Infants below the age of 1 year should not be given ACE inhibitors due to concerns over possible effects on kidney development * The clearance rate was substantially higher in hypertensive children and adolescents than that of healthy adults * The terminal half life (t1/2) in pediatric patients was one third of that observed in adults * Adverse event profile in pediatric patients was similar to that seen in adults * Information on preparation of a suspension Antihypertensive
02/27/2004 Myfortic Delayed-Release Tablets mycophenolic acid Prevention of organ rejection in patients receiving allogeneic renal transplants in children 5-16 years of age with stable renal transplants * Approval based on extrapolation of safety and effectiveness in adult patients * One PK study with information down to 5 years of age * Waived studies in birth to 10 years because there are too few children to study. * New active ingredient Immunosuppressant
02/24/2004 Children's Advil Allergy Sinus Suspension chlorpheniramine; ibuprofen; pseudoephedrine Symptoms of allergic rhinitis (runny nose) and the common cold in children 6 years of age and older * Effectiveness extrapolated from adult studies * Bioequivalence studies in healthy adults * PK and safety studies in children 6 to 12 years of age * New dosage form Antihistamine
01/15/2004 Zithromax Tablets azithromycin Treatment of acute bacterial sinusitis (sinus infection) in patients 6 months of age and older * Effectiveness extrapolated from adult sinusitis studies and from pediatric acute otitis media studies * Clinical studies conducted in pediatric patients 3 years to 16 years of age to determine PK and safety for oral suspension * Safety and effectiveness in patients under 6 months of age have not been established * Side effects seen in pediatric patients were comparable to those seen in adults, with different incidence rates for the dosage regimens recommended in pediatric patients * Dosing regimen established * Partial waiver < 6 months of age because too few patients to study * New indication Antibiotic
01/08/2004 Norvasc amlodipine Hypertension * Information on dose, PK in pediatric patients 6-17 years of age * Adverse event profile in pediatric patients was similar to that seen in adults Antihypertensive
12/12/2003 Xenical orlistat Obesity management * Use in 12-16 year olds is supported by studies in adults with additional data from a 54 week safety and efficacy study in obese adolescent patients. * Since orlistat can reduce absorption of fat soluble vitamins, all patients should take a daily multivitamin supplement containing fat soluble vitamins. * Adverse event profile in adolescent patients was similar to that seen in adults Obesity management
12/10/2003 Ertaczo Cream sertaconazole Treatment of interdigital tinea pedis (athlete's foot) in children 12 years of age and older * Safety and effectiveness established in clinical trials involving adolescent patients * Studies in patients less than 12 years of age waived because there are too few children with the disease to study * New drug Antifungal, topical
12/02/2003 Malarone atovaquone/ proguanil Prophylaxis and treatment of malaria * Safety and effectiveness established down to e 11kg * Information on dose, efficacy, PK parameters and AE profile * Elimination half-life is shorter in pediatric patients (1 to 2 days) than in adults (2 to 3 days) * Attributable AEs occurring in ³ 5% of the pediatric patients were vomiting (10%) and pruritus (6%) Antimalarial

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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.

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