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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 558
n = 508 with New Pediatric Studies; n = 50 with No New Pediatric Studies
BPCA only = 162; BPCA + PREA = 76; PREA only = 270; Rule = 49; None = 1

Pediatric Labeling Changes as of March 26, 2015

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:  558
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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
02/14/2002 Mevacor lovastatin Heterozygous Familial Hypercholesterolemia * New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years of age Antilipemic
02/08/2002 Acular & Acular PF ketorolac Relief of ocular itching due to seasonal allergic rhinitis and postoperative inflammation after cataract extraction * Safety and effectiveness established down to 3 years; previously approved down to 12 years Anti-inflammatory
02/08/2002 Clarinex Tablets desloratadine Relief of pruritis/hives in patients with chronic idiopathic urticaria * Approved down to 12 years of age Antihistamine
02/08/2002 Clarinex Tablets desloratadine Perennial allergic rhinitis * Approved down to 12 years of age Antihistamine
01/30/2002 Xopenex Inhalation Solution levalbuterol Treatment and prevention of bronchspasm * Approved down to 6 years of age; recommended dose is 0.31mg TID for patients 6-11 years of age Antiasthmatic
01/25/2002 Daypro oxaprozin Relief of signs and symptoms of Juvenile Rheumatoid Arthritis * New indication in 6 years -16 years Anti-inflammatory
12/28/2001 Rebetron; Rebetrol ribavirin/intron a; ribavirin Chronic hepatitis C * Labeling for 3 years to 16 years * There are no safety and efficacy data on treatment for longer than 48 weeks in pediatric patients * Pharmacokinetic information on patients 5 to 16 years with chronic hepatitis C virus infection * Increased incidence of suicidal ideation or attempts (2.4% versus 1%) among pediatric patients compared to adult patients * Decrease in rate of linear growth (mean percentile assignment decrease of 9%) and in rate of weight gain (mean percentile assignment decrease of 13%) during 48 weeks of treatment; a general reversal was noted during the 24 week post treatment period * Patients with viral genotype 1, had a lower response rate to combination therapy compared to patients with genotype non-1, 36% versus 81% * In general, the adverse event profile in the pediatric population was similar to that observed in adults * New oral suspension developed Antiviral
12/21/2001 Clarinex Tablets desloratadine Seasonal allergic rhinitis * Approved down to 12 years of age Antihistamine
12/20/2001 Alphagan brimonidine Prevention of post-operative IOP elevations * Safety and effectiveness established down to 2 years * Somnolence in patients 2 to 6 years (50-83%) versus patients 7 years of age or older (25%) Ophthalmologic hypotensive
12/13/2001 Elidel pimecrolimus Treatment of mild/moderate atopic dermatitis * Indicated for short-term and intermittent long-term therapy for mild to moderate atopic dermatitis in non-immunocompromised patients 2 years and older * Not recommended for use in pediatric patients less than 2 years of age. Infants on Elidel Cream had an increased incidence of some adverse events compared to vehicle which included pyrexia, URI, nasopharyngitis, gastroenteritis, otitis media, and diarrhea. Immunomodulator
11/16/2001 Calcijex calcitriol Management of hypocalcemia in patients undergoing chronic renal dialysis * The safety and effectiveness of calcitriol was examined in a double-blind placebo-controlled trial of 35 pediatric patients (13-18 years of age) with end-stage renal disease and on dialysis. * The primary efficacy endpoint favored the calcitriol-treated versus the placebo-treated patients * Transient hypercalcemia was seen in 1 of 16 calcitriol-treated patients; 6 of 16 (38%) calcitriol-treated patients and 2 of 19 (11%) placebo-treated patients had Ca x P >75 Vitamin
11/13/2001 Focalin dexmethylphenidate Attention Deficit Hyperactivity Disorder Pending CNS Stimulant
10/10/2001 Derma-Smoothe/FS Topical Oil fluocinolone Atopic dermatitis * Approved down to 2 years of age Anti-inflammatory, topical
10/03/2001 Diprolene AF, Diprosone, Lotrisone betamethason;betamethasone/ clotrimazole Diprolene AF and Diprosone - Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses Lotrisone- Treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis * Diprolene AF Cream * In an open-label study for the treatment of atopic dermatitis, 19 of 60 (32%) evaluable patients (ages 3 mo-12 years) showed HPA axis suppression. The younger the age group, the greater the proportion of patients with adrenal suppression. * Indicated in patients 13 years and older. Not recommended in pediatric patients 12 years and younger * Strengthened labeling in Clinical Pharmacology, Precautions- General and Pediatric Use subsections * Local adverse reactions including signs of skin atrophy (telengiectasia, bruising, shininess) occurred in 10% of pediatric patients (3mo-12 years) * Diprosone Cream, Ointment, Lotion * A separate open-label study was performed in pediatric patients with atopic dermatitis for each Diprosone formulation * Testing for HPA axis suppression was positive with each formulation in the age groups studied: Cream - 23% (ages 2yr-12yr); Ointment - 28% (ages 6mo-12yr); and Lotion - 73% (ages 6yr-12yr) * Indicated in patients 13 years and older. Not recommended in pediatric patients 12 years and younger * Strengthened labeling in Clinical Pharmacology, Precautions- General and Pediatric Use subsections * Local adverse reactions including signs of skin atrophy (telengiectasia, bruising, shininess) occurred in the cream and ointment studies * Lotrisone * Not recommended for patients under the age of 17 years and not recommended for diaper dermatitis; previously not recommended for patients under the age of 12 years * In an open-label study of Lotrisone cream for the treatment of tinea pedis, 17 of 43 (39.5%) evaluable patients (ages 12-16 years) demonstrated adrenal suppression as determined by cosyntropin testing * In an open-label study of Lotrisone cream for the treatment of tinea cruris, 8 of 17 (47.1%) evaluable patients (ages 12-16 years) demonstrated adrenal suppression by cosyntropin testing * Indicated in patients 17 years and older Anti-inflammatory, topical
10/01/2001 Betapace sotalol Arrhythmia * Analysis of 2 trials provided information on PK and PD in children 3 days  12 years; safety and efficacy have not been established * Information on dose, pharmacokinetics and AE's * Pharmacokinetics: BSA most important covariate and more relevant than age * Smaller children (BSA < 0.33 m2) showed tendency for larger change in QTc and increased frequency of prolongation of the QTc interval as well as greater beta-blocking effects * Individualized dosing on a mg/m2 basis * Information on preparation of a suspension Antiarrhythmic
08/28/2001 Topamax Tablets and Sprinkle Capsules topiramate Seizures associated with Lennox-Gastaut syndrome * Approved for treatment down to 2 years of age Anticonvulsant
08/16/2001 Epivir-HBV lamivudine Treatment of Chronic Hepatitis B * Safety and effectiveness established down to 2 years * Established a dose of 3mg/kg/day up to a maximum of 100mg/day (adult dose) Antiviral
07/19/2001 Buspar buspirone General Anxiety Disorder * Safety and effectiveness were not established in patients 6 to 17 years of age for treatment of General Anxiety Disorder at doses recommended for use in adults * PK parameters (AUC and Cmax) of buspirone and its active metabolite were found to be equal to or higher in children and adolescents than that of adults Antianxiety
06/25/2001 Valtrex Caplets valacyclovir Treatment of cold sores * New indication approved for use down to 12 years of age Antiviral
06/06/2001 Mentax Cream butenafine Tinea versicolor * Approved down to 12 years of age; previously approved in adults only Antifungal, topical

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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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