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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 528
n = 479 with New Pediatric Studies; n = 49 with No New Pediatric Studies
BPCA only = 159; BPCA + PREA = 71; PREA only = 247; Rule = 50; None = 1

Pediatric Labeling Changes as of August 4,2014

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:  528
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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
10/16/2003 Elestat Ophthalmic Solution epinastine Prevention of itching associated with allergic conjunctivitis in children 3 years of age and older * Based on effectiveness and safety studies that included children down to 10 years of age * Partial waiver for children < 3 years of age because the condition does not exist in the age group * New drug Antihistamine, topical
10/10/2003 Denavir Cream penciclovir Treatment of recurrent herpes labialis (cold sores) in children 12 years of age and older * Extended indication down from 18 years of age to 12 years of age * Effectiveness extrapolated from adult studies * Safety study in patients 12-17 years of age * Pediatric submission Antiviral, topical
09/30/2003 Floxin Otic Solution ofloxacin Treatment of otitis externa (outer ear infection) in children 6 months of age and older * Dosing change from 2 times daily to 1 time daily for 7 days based on effectiveness and safety studies that included pediatric patients * New dosing regimen Antibiotic
08/01/2003 Fludara fludarabine Refractory acute leukemia and solid tumors * Fludarabine was evaluated in 62 pediatric patients and the data were insufficient to establish efficacy in any childhood malignancy Antineoplastic
07/18/2003 Ciprodex Sterile Otic Suspension ciprofloxacin; dexamethasone Treatment of acute otitis media in patients with tympanostomy tubes (inner ear infection) in children 6 months of age and older treatment of acute otitis externa (outer ear infection) in children 6 months of age and older * Over 700 pediatric patients in safety and effectiveness studies to support both indications * Pediatric dosing information added * New dosage form Antibiotic, topical
07/01/2003 Zestril lisinopril Hypertension * Labeling for 6-16 years of age * Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/min/1.73m2 * Information on dose, efficacy and pharmacokinetics * No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients * Information on preparation of a suspension Antihypertensive
05/29/2003 Prinivil lisinopril Hypertension * Labeling for 6-16 years of age * Not recommended for pediatric patients with glomerular filtration rate < 30ml/min/1.73m2 * Information on dose, efficacy and pharmacokinetics * No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients * Information on preparation of a suspension Antihypertensive
05/27/2003 Monopril fosinopril Hypertension * New data from a double-blind study in 252 patients 6-16 years of age * New recommended dose in children weighing more than 50kg * New Information on PK parameters * An appropriate dosage strength is not available for children weighing less than 50kg Antihypertensive
05/23/2003 Duocaine Injection bupivacaine; lidocaine Local regional anesthesia for ophthalmologic surgery by peripheral nerve block techniques in children 12 years of age and older * Safety and effectiveness extrapolated from existing clinical database * Safety and effectiveness not established in patients < 12 years of age * Partial waiver 0-12 years of age because general anesthesia is preferred in that population * New active ingredient Anesthetic, topical
05/20/2003 Duragesic fentanyl Management of chronic pain * Safety evaluated in three open-label trials in 291 patients 2 years through 18 years of age with chronic pain * New Warning: Duragesic should be administered to children only if they are opioid-tolerant and age 2 years or older * New information on pharmacokinetics, dosage and administration and patient information * Precaution to guard against accidental ingestions by children * Adverse Events: no apparent pediatric-specific risk associated with Duragesic use in children as young as 2 years old when used as directed. Most common adverse events were fever (35%), vomiting (33%), and nausea (24%) Anesthetic agent
05/12/2003 Allegra fexofenadine Allergic rhinitis * Three clinical safety studies in 845 children with allergic rhinitis are described in the label Antihistamine
05/01/2003 Flonase Nasal Spray & Cultivate Ointment fluticasone Flonase - nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis Cutivate Ointment - corticosteroid-responsive dermatoses Flonase * New data from 1-year placebo-controlled clinical growth study in pediatric patients 3-9 years of age; no statistically significant effect on growth was noted compared to placebo. No evidence of clinically relevant changes in HPA axis function or bone mineral density was observed as assessed by 12-hour urinary cortisol excretion and dual-energy x-ray absorptiometry, respectively. Cutivate * Indicated for use only in adult patients * In a study of 35 pediatric patients treated for atopic dermatitis, subnormal adrenal function was observed with cosyntropin stimulation testing Anti-inflammatory, topical
04/15/2003 Methylin Chewable Tablets methylphenidate Treatment of Attention-Deficit Hyperactivity Disorder in children 6 years of age and older treatment of narcolepsy in children 6 years of age and older * Bioequivalence studies in adults * New dosage form CNS Stimulant
04/15/2003 Ditropan & Ditropan XL oxybutynin Detrusor Overactivity Associated with a Neurological Condition Ditropan * Additional information on dose and PK parameters * Precautions section of label updated Ditropan XL * Safety and effectiveness established down to 6 years of age Urology
04/15/2003 Vigamox moxifloxacin Bacterial Conjunctivitis * Safety and effectiveness established down to 1 year of age Antibiotic, topical
03/11/2003 Temodar temozolomide Recurrent CNS tumors * Temozolomide effectiveness in children has not been demonstrated * New data from 2 open-label Phase 2 studies in pediatric patients 3-18 years of age. In one study there were 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocyoma. In a second study there were 122 patients enrolled with various types of tumors; 113 CNS tumors and 9 non-CNS tumors. * The temozolomide toxicity profile in children is similar to adults Antineoplastic
02/26/2003 Pulmicort budesonide Maintenance and Prophylaxis of Asthma * Safety information in pediatric patients 6 to 12 months of age * A dose dependent effect on growth was observed in the 12-week trial which supports the finding that the use of Pulmicort Respules in infants 6 to 12 months of age may result in systemic effects and is consistent with the findings of growth suppression in other studies with inhaled corticosteroids * Pneumonia was observed more frequently in patients treated with Pulmicort Respules than in patients treated with placebo Antiasthmatic
01/17/2003 Lamictal lamotrigine Adjunctive therapy for partial seizures * Extended indication from adults to pediatric patients e 2 years * Patients aged 2 - 18 years had clearance influenced predominantly by total body weight and concurrent antiepileptic drug (AED) therapy. The oral clearance was higher, on a body weight basis, in pediatric patients than in adults * Because of increased clearance in pediatrics, maintenance doses in patients weighing < 30 kg may need an increase of as much as 50% based upon clinical response * Evidence shows that the inclusion of VPA in a multi-drug regimen increases the risk of serious, potentially life-threatening rash in pediatric patients * Approximately 11.5% of the 1,081 pediatric patients who received the drug as adjunctive therapy in clinical trials discontinued treatment because of an AE Anticonvulsant
01/13/2003 Busulfex busulfan Part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases * The population pharmacokinetic estimates of busulfan for clearance and volume of distribution were determined in an open-label, uncontrolled PK study in 24 pediatric patients 5 months to 16 years who received busulfan as part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases * Suggested dosing regimen Antineoplastic
01/03/2003 Prozac fluoxetine Major Depressive Disorder (MDD) & Obsessive Compulsive Disorder (OCD) * Effectiveness established in patients 7-17 years of age for OCD * Effectiveness established in patients 8-17 years of age for MDD * 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 Prozac 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. Prozac is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD). (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 * Decreased weight gain has been observed in association with the use of fluoxetine, as with other SSRIs. In one 19-week clinical trial pediatric subjects treated with fluoxetine gained an average of 1.1cm less in height (p=0.004) and 1.1 kg less in weight (p=0.008) than those treated with placebo. Therefore, height and weight should be monitored periodically in pediatric patients treated with fluoxetine * Mania/hypomania led to discontinuation of 1.8% of fluoxetine treated patients vs. 0% of placebo controlled patients in the three placebo-controlled trials combined. Regular monitoring for the occurrence of mania/hypomania is recommended * Higher average steady state fluoxetine and norfluoxetine concentrations were observed in children than in adolescents. These differences were almost entirely explained by differences in weight * Separate dosing recommendations in lower weight children Antidepressant
12/31/2002 Singulair Oral Granules, Tablets, and Chewable Tablets montelukast Seasonal allergic rhinitis in children 2 years of age and older *Effectiveness extrapolated from studies in patients 15 years of age and older and supported with one pediatric safety trial in patients 2-14 years of age *New indication Antiasthmatic; antiallergy
12/30/2002 Zovirax Cream acyclovir Treatment of herpes labialis (cold sores) in children 12 years and older * Adolescents 12-17 years of age included in clinical safety studies. * dosing regimen established waived in children < 12 years of age because rarely seen in that population * New dosage form Antiviral
12/26/2002 Relpax eletriptan Migraine *Su mmary is pending Antimigraine
12/19/2002 Zyvox linezolid Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains * Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years * Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds * Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults * Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults * New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older * Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies Antibiotic
12/04/2002 Centany Ointment 2% mupirocin Treatment of impetigo in children 2 months of age and older * New dosage form: ointment that differed from already approved ointment with pediatric clinical trials to demonstrate equivalence Antibiotic, topical
11/26/2002 Strattera atomoxetine Attention-Deficit Hyperactivity Disorder * Safety and effectiveness established down to 6 years of age * It is unknown whether final adult height or weight is affected by treatment. Patients on long-term treatment should be monitored * The effectiveness of atomoxetine beyond 9 weeks and safety beyond 1 year in pediatric patients, has not been systematically evaluated in controlled trials Non-stimulant ADHD treatment
11/05/2002 Navelbine vinorelbine Malignant tumors * New data from a single-arm study in 46 patients with recurrent solid malignant tumors, including rhabdomyosarcoma /undifferentiated sarcoma, neuroblastoma, and CNS tumors, at doses similar to those used in adults showed no meaningful clinical activity Antineoplastic
10/29/2002 Pravachol pravastatin Heterozygous Familial Hypercholesterolemia * New indication in boys and girls 8-18 years of age Antilipemic
10/21/2002 Zyrtec cetirizine Perennial Allergic Rhinitis & Chronic Urticaria * Extended the age range from 2 years to 6 months * Information on dose, PK parameters and AE profile Antihistamine
10/18/2002 Lipitor atorvastatin Heterozygous Familial Hypercholesterolemia * New indication in adolescent boys and girls (post-menarche) 10-17 years of age Antilipemic
10/18/2002 Zocor simvastatin Heterozygous Familial Hypercholesterolemia * New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years of age Antilipemic
10/08/2002 Epivir lamivudine HIV * Lamivudine clearance substantially reduced in 1-week-old neonates relative to pediatric patients >3 months of age Antiviral
08/30/2002 Nolvadex tamoxifen McCune-Albright Syndrome * A study in 28 female patients aged 2-10 years with McCune-Albright Syndrome and precocious puberty did not demonstrate safety and effectiveness. Long term effects have not been established * Mean uterine volume increased after 6 months of therapy and doubled at end of 1-year study Hormone
08/26/2002 DUAC Topical Gel clindamycin 1%/benzoyl peroxide 5% Acne * Added combination topical treatment for mild to moderate acne Antiacne, topical
07/26/2002 Singulair montelukast Prophylaxis and chronic treatment of asthma *Safety and effectiveness established in patients 12 months to 5 years of age *Information on dose, PK parameters and AE profile in patients 12-23 months and 2-5 years *New 4mg chewable tablet and 4mg oral granule formulations developed. The chewable tablets contain aspartame whereas the oral granule formulation does not Antiasthmatic
07/17/2002 Nasonex-nasal Elocon - topical mometasone Nasonex - Perennial and seasonal allergic rhinitis Elocon - Relief of inflammatory and pruritic manifestations of corticosteroid dermatose * Nasonex Nasal Spray * Extended age range from 3 years down to 2 years * In a clinical study in which pediatric patients 2-5 years were treated with mometasone nasal spray for up to 42 consecutive days, no significant effect on adrenal function was found * Upper respiratory tract infection was more common with Nasonex (2/28) compared to placebo (0/28) * Elocon Cream & Ointment * Evidence of HPA axis suppression in pediatric patients 6-23 months of age * Outlined local AE's as well as skin atrophy in pediatric patients 6-23 months of age * Approved down to 2 years of age as in previous labeling * Elocon Lotion * Safety and effectiveness have not been established in pediatric patients below 12 years of age and use <12 year old is not recommended * Should not be used for the treatment of diaper dermatitis Anti-inflammatory, topical
07/12/2002 Prilosec omeprazole Gastroesophageal reflux and erosive esophagitis * Safety and effectiveness established in pediatric patients 2-16 years of age * Information on dose, PK parameters, exposure/response and AE profile Antiulcerative
06/26/2002 Clarinex RediTabs Orally Disintegrating Tablets desloratadine Allergic rhinitis and chronic ideopathic urticaria * Approved for use down to 12 years of age; new formulation Antihistamine
06/06/2002 Pepcid famotidine Gastroesophageal reflux * Labeling for patients less than 1 year of age including information on dose, PK/PD parameters and AE profile * Lower dose recommended in patients <3 months of age * Pediatric patients 0-3 months of age had clearance values 2 to 4-fold less than those in older patients and adults * In a clinical study of 35 pediatric patients <1 year of age, agitation was observed in 5 patients on famotidine and resolved upon discontinuation of the drug Antiulcerative
06/05/2002 Ritalin LA Capsules methylphenidate Attention Deficit Hyperactivity Disorder * Approved for use in 6-12 years of age; once a day dose in the morning CNS Stimulant
05/10/2002 QVAR beclomethasone dipropionate Maintenance treatment of asthma as prophylactic therapy Summary is pending Antiasthmatic
05/02/2002 Accutane isotretinoin Severe recalcitrant nodular acne * Safety and effectiveness information on pediatric patients 12-17 years of age * Identified an increased incidence of back pain, arthralgia and myalgia in pediatric patients * New General Precautions subsection- caution when prescribing Accutane to pediatric patients with disorders of bone metabolism, such as osteoporosis and osteomalacia * Adolescents who participate in sports with a repetitive impact may be at increased risk for bone related injuries * In an open-label study of pediatric patients (n=217) given a single course of therapy, 16 (7.9%) had decreases in lumbar spine bone mineral density (BMD) >4% (adjusted for body mass index); 21 (10.6%) patients had decreases in total hip BMD >5% (adjusted for body mass index) Antiacne
04/18/2002 Advil Cold Suspension ibuprofen/ pseudoephedrine Temporary relief of nasal and sinus congestion, headache, stuffy nose, sore throat, minor aches and pains, and fever * Information on the over-the-counter use in pediatric patients 2 to 11 years of age Decongestant; anti-inflammatory
04/01/2002 Videx didanosine HIV infection * Safety and effectiveness established down to 2 weeks Antiviral
03/29/2002 Zerit stavudine HIV infection * Safety and effectiveness established down to birth * Established a dose for newborns from birth to 13 days Antiviral

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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:

Biological labeling and reviews:

BPCA 2002 Review Summaries:

**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.