FDA labeling changes(Total Drugs:82) |
|---|
| DiseaseID |
Pediatric_Labeling_Date |
Trade_Name |
Generic_Name_or_Proper_Name |
Indications Studied |
Label Changes Summary |
Product Labeling |
BPCA(B) |
PREA(P) |
BPCA(B) and PREA(P) |
Pediatric Rule (R) |
Sponsor |
Pediatric Exclusivity Granted Date |
NNPS |
| MESH:D006261 | 4/12/2000 | claritin | loratadine | Allergic rhinitis/Urticaria | Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence | Labeling | B | - | - | - | Schering | 08/14/2000 | FALSE' |
| MESH:D006261 | 4/12/2000 | claritin | loratadine | Allergic rhinitis/Urticaria | Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence | Labeling | B | - | - | - | Schering | 08/14/2000 | FALSE' |
| MESH:D006261 | 4/12/2000 | claritin | loratadine | Allergic rhinitis/Urticaria | Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence | Labeling | B | - | - | - | Schering | 08/14/2000 | FALSE' |
| MESH:D006261 | 4/12/2000 | claritin | loratadine | Allergic rhinitis/Urticaria | Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence | Labeling | B | - | - | - | Schering | 08/14/2000 | FALSE' |
| MESH:D006261 | 4/12/2000 | claritin | loratadine | Allergic rhinitis/Urticaria | Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence | Labeling | B | - | - | - | Schering | 08/14/2000 | FALSE' |
| MESH:D006261 | 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 | Labeling | B | - | - | - | Merck | 07/17/2001 | FALSE' |
| MESH:D006261 | 12/7/2002 | 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 | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
| MESH:D006261 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
| MESH:D006261 | 12/7/2002 | 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 | Labeling | B | - | - | - | AstraZeneca | - | FALSE' |
| MESH:D006261 | 03/20/2008 | prilosec | omeprazole | Maintenance healing of erosive esophagitis | Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. Safety and effectiveness in children less than 1 year of age have not been established Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. New dosage form | Labeling | - | - | B, P | - | AstraZeneca | 1/5/2001 | FALSE' |
| MESH:D006261 | 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 | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D006261 | 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 | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D006261 | 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 | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D006261 | 12/5/2005 | 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 | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D006261 | 12/5/2005 | 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 | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D006261 | 12/5/2005 | 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 | Labeling | B | - | - | - | Pfizer | 11/2/2005 | FALSE' |
| MESH:D006261 | 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 | Labeling | B | - | - | - | GlaxoSmithKline | 02/14/2007 | FALSE' |
| MESH:D006261 | 8/5/2009 | lamictal | lamotrigine | Adjunctive treatment for partial seizures in pediatric patients 1 24 months | Safety and effectiveness as adjunctive treatment for partial seizures were not demonstrated in a small randomized, double-blind, placebo-controlled, withdrawal study in pediatric patients 1 - 24 months Immediate release tablets were associated with an increased risk for infectious adverse reactions including bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection (Lamictal 37%, Placebo 5%), and respiratory adverse reactions including nasal congestion, cough, and apnea. (Lamictal 26%, Placebo 5%) | Labeling | B | - | - | - | GlaxoSmithKline | 02/14/2007 | FALSE' |
| MESH:D006261 | 05/18/2015 | lamictal | lamotrigine | Maintenance treatment of bipolar disorder | Safety and efficacy for the maintenance treatment of bipolar disorder were not established in a double-blind, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 Information on clinical trial and adverse reactions Postmarketing study | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE |
| MESH:D006261 | 05/29/2009 | lamictal xr | lamotrigine | Adjunctive therapy for partial onset seizures in patients e13 years of age | Extended release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients e13 years Safety and effectiveness of extended release tablets for any use in patients below the age of 13 have not been established Information on adverse event profile, and clinical studies New dosage form | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D006261 | 01/29/2010 | lamictal xr | lamotrigine | Adjunctive therapy for Primary Generalized Tonic-Clonic seizures | New indication for adjunctive therapy for primary generalized tonic-clonic seizures in patients e 13 years of age Safety and effectiveness for any use in patients < 13 years have not been established Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D006261 | 04/25/2011 | lamictal xr | lamotrigine | Monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug (AED) | Approved for conversion to monotherapy in patients e13 years of age with partial seizures receiving treatment with a single antiepileptic drug (AED).Safety and effectiveness have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from two or more concomitant AEDsInformation on conversion to monotherapy, adverse reactions, clinical trialNew indication | Labeling | - | P | - | - | GlaxoSmithKline | - | FALSE' |
| MESH:D006261 | 11/3/2003 | 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 | Labeling | B | - | - | - | Schering | 11/20/2002 | FALSE' |
| MESH:D006261 | 11/3/2003 | 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 | Labeling | B | - | - | - | Schering | 11/20/2002 | FALSE' |
| MESH:D006261 | 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 | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D006261 | 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 | Labeling | B | - | - | - | Bayer | 12/18/2003 | FALSE' |
| MESH:D006261 | 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 | Labeling | B | - | - | - | Tap | 07/15/2008 | FALSE' |
| MESH:D006261 | 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 | Labeling | B | - | - | - | Tap | 07/15/2008 | FALSE' |
| MESH:D006261 | 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 | Labeling | B | - | - | - | Tap | 07/15/2008 | FALSE' |
| MESH:D006261 | 10/28/2008 | prevacid | lansoprazole | Symptomatic GERD in infants | Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies | Labeling | - | - | B, P | - | Takeda | 07/15/2008 | FALSE' |
| MESH:D006261 | 10/28/2008 | prevacid | lansoprazole | Symptomatic GERD in infants | Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies | Labeling | - | - | B, P | - | Takeda | 07/15/2008 | FALSE' |
| MESH:D006261 | 10/28/2008 | prevacid | lansoprazole | Symptomatic GERD in infants | Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age AE profile similar to that observed in adultsInformation on PK parameters in neonates to < 1 year, and clinical studies | Labeling | - | - | B, P | - | Takeda | 07/15/2008 | FALSE' |
| MESH:D006261 | 12/1/2005 | 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 | Labeling | B | - | - | - | Organon | - | FALSE' |
| MESH:D006261 | 6/4/2006 | daytrana | methylphenidate | ADHD | Summary is pending | Labeling | - | P | - | - | Shire | - | FALSE' |
| MESH:D006261 | 12/14/2009 | daytrana | methylphenidate | Postmarketing safety study | Information added to Warnings and Adverse Reactions on skin reactions observed in a postmarketing dermal study in pediatric patients | Labeling | - | P | - | - | Shire | - | FALSE' |
| MESH:D006261 | 06/29/2010 | daytrana | methylphenidate | ADHD | Expanded pediatric indication to include adolescent patients ages13-17 years The most commonly reported adverse reactions in a trial in patients 13-17 years included appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia. The majority of patients had erythema at the application site Information on PK parameters, Adverse Event profile and clinical studies | Labeling | - | P | - | - | Shire | - | FALSE' |
| MESH:D006261 | 12/15/2006 | celebrex | celecoxib | Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) | New indication in 2 years and older Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults New 50 mg capsule developed Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules Information on dose, clinical studies, PK parameters, AEs | Labeling | B | - | - | - | Pfizer | 08/23/2006 | FALSE' |
| MESH:D006261 | 12/15/2006 | celebrex | celecoxib | Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) | New indication in 2 years and older Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults New 50 mg capsule developed Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules Information on dose, clinical studies, PK parameters, AEs | Labeling | B | - | - | - | Pfizer | 08/23/2006 | FALSE' |
| MESH:D006261 | 10/1/2007 | eloxatin | oxaliplatin | Solid tumors | The effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEs | Labeling | B | - | - | - | Sanofi-Aventis | 09/27/2006 | FALSE' |
| MESH:D006261 | 10/1/2007 | eloxatin | oxaliplatin | Solid tumors | The effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEs | Labeling | B | - | - | - | Sanofi-Aventis | 09/27/2006 | FALSE' |
| MESH:D006261 | 10/1/2007 | eloxatin | oxaliplatin | Solid tumors | The effectiveness of oxaliplatin in children has not been established No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors Information on clinical studies and AEs | Labeling | B | - | - | - | Sanofi-Aventis | 09/27/2006 | FALSE' |
| MESH:D006261 | 08/17/2007 | provigil | modafinil | Narcolepsy | Modafinil is not approved for use in pediatric patients for any indication Safety and effectiveness were not demonstrated in a controlled 6-week study in 165 pediatric patients 5-17 years with narcolepsy Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil In the controlled and open-label clinical studies, treatment emergent adverse events of the psychiatric and nervous system included Tourettes syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations and suicidal ideation Information on safety, AEs and clinical study | Labeling | B | - | - | - | Cephalon, Inc | 03/21/2006 | FALSE' |
| MESH:D006261 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D006261 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D006261 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D006261 | 10/29/2007 | abilify | aripiprazole | Schizophrenia | Extended schizophrenia indication from adults to adolescents 1317 years Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated In 6-week placebo controlled efficacy trial in patients 13 17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship Information on dose, AEs, clinical studies | Labeling | B | - | - | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D006261 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D006261 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D006261 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D006261 | 02/27/2008 | abilify | aripiprazole | Bipolar I Disorder | Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10 17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies | Labeling | - | - | B, P | - | Otsuka | 11/14/2007 | FALSE' |
| MESH:D006261 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D006261 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D006261 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D006261 | 11/19/2009 | abilify | aripiprazole | Irritability associated with autistic disorder | Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. Information on dosing, adverse reactions, and clinical studies | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D006261 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D006261 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D006261 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D006261 | 9/6/2014 | abilify | aripiprazole | Maintenance treatment of irritability associated with autistic disorder | Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study | Labeling | - | P | - | - | Otsuka | - | FALSE' |
| MESH:D006261 | 11/29/2007 | diovan | valsartan | Hypertension | Labeling for 6-16 years of age Not recommended for pediatric patients less than 6 years due to safety findings possibly related to treatment or with glomerular filtration rate < 30mL/min/1.73m2 Information on dose, clinical studies in 1-16 years 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 | Labeling | B | - | - | - | Novartis | 8/8/2007 | FALSE' |
| MESH:D006261 | 11/29/2007 | diovan | valsartan | Hypertension | Labeling for 6-16 years of age Not recommended for pediatric patients less than 6 years due to safety findings possibly related to treatment or with glomerular filtration rate < 30mL/min/1.73m2 Information on dose, clinical studies in 1-16 years 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 | Labeling | B | - | - | - | Novartis | 8/8/2007 | FALSE' |
| MESH:D006261 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D006261 | 08/14/2008 | zyprexa | olanzapine | schizophrenia; bipolar disorder | Safety and effectiveness have not been established for patients less than 18 years of age In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight gain olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg | - | B | - | - | - | Lilly | 10/1/2007 | FALSE' |
| MESH:D006261 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |
| MESH:D006261 | 4/12/2009 | zyprexa | olanzapine | Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 | Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age Safety and effectiveness in children < 13 years of age have not been established Recommended starting dose for adolescents is lower than that for adults Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels Information on dosing, adverse reactions, pharmacokinetics, clinical studies | Labeling | B | - | - | - | Lilly | 10/1/2007 | TRUE' |
| MESH:D006261 | 1/10/2009 | mirena | levonorgestrel-releasing intrauterine system | Treatment of heavy menstrual bleeding for women using intrauterine contraception | New indication for the treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception Use before menarche is not indicated | Labeling | - | P | - | - | Berlex | - | TRUE' |
| MESH:D006261 | 10/7/2009 | plan b one step | levonorgestrel | Emergency contraception - OTC in women 17 years and older; RX for women younger than age 17 years | New single dose 1.5 mg tablet New dosage regimen | Labeling | - | P | - | - | Duramed | - | FALSE' |
| MESH:D006261 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D006261 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D006261 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D006261 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D006261 | 09/19/2008 | retrovir syrup, capsules and tablets | zidovudine | Used in combination with 18 other antiretroviral agents for the treatment of HIV-1 infection | Dosing and administration information provided to children 6 weeks to less than 18 years of age Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies New dosing regimen | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D006261 | 6/11/2009 | retrovir | zidovudine | Treatment of HIV-1 infection in combination with other antiretroviral agents | Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg | Labeling | - | P | - | - | GlaxoSmithKline | - | TRUE' |
| MESH:D006261 | 2/11/2010 | ofirmev | acetaminophen | Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever | The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administration | Labeling | - | P | - | - | Cadence | - | FALSE' |
| MESH:D006261 | 01/27/2017 | ofirmev | acetaminophen | Treatmeny of pain and fever in pediatric patients birth to 2 years | Treatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study. | Labeling | - | - | B,P | - | Mallinckrodt | 11/7/2016 | FALSE |
| MESH:D006261 | 2/11/2010 | ofirmev | acetaminophen | Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever | The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and olderMost common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.Information on dosing, clinical studies, adverse reactions and PK parametersNew dosage form and route of administration | Labeling | - | P | - | - | Cadence | - | FALSE' |
| MESH:D006261 | 01/27/2017 | ofirmev | acetaminophen | Treatmeny of pain and fever in pediatric patients birth to 2 years | Treatment of pain Efficacy was not demonstrated in pediatric patients younger than 2 years in a double-blind, placebo-controlled study of 198 pediatric patients younger than 2 years. Pediatric patients less than 2 years of age, including neonates from 28 to 40 weeks gestational age at birth, were randomized to receive opioid plus acetaminophen or opioid plus placebo. No difference in analgesic effect of intravenous acetaminophen, measured by assessment of reduced need for additional opioid treatment for pain control, was observed. Treatment of fever The safety and effectiveness for the treatment of fever in pediatric patients, including premature neonates born at 32 weeks or greater gestation is supported by adequate and well-controlled studies of Ofirmev in adults, clinical studies in 244 pediatric patients 2 years and older, and safety and pharmacokinetic data from 239 patients younger than 2 years including neonates 32 weeks or greater gestational age. Information on dosing, clinical trials. Postmarketing study. | Labeling | - | - | B,P | - | Mallinckrodt | 11/7/2016 | FALSE |
| MESH:D006261 | 12/21/2010 | inomax | nitric oxide | Prevention of bronchopulmonary dysplasia | INOmax is not indicated for prevention of BPD in preterm neonates d 34 weeks gestational age.Efficacy for the prevention of BPD in preterm infants was not established in three ldouble-blind, placebo-controlled clinical trials in a total of 2,149 preterm infants Information on clinical trials, adverse reaction | Labeling | B | - | - | - | INO Therapeutics | 2/11/2010 | FALSE' |
| MESH:D006261 | 01/23/2013 | exjade | deferasirox | Treatment of chronic iron overload in patients with non-transfusion dependent thalassemia | Approved for use in 10 years and older for NTDT Safety and effectiveness have not been established in pediatric patients less than 10 years Information on dosing, adverse reactions in adults and pediatric patients, and clinical trials New indication | Labeling | - | P | - | - | Novalar Pharmaceuticals, Inc. | - | FALSE' |
| MESH:D006261 | 10/26/2013 | sabril | vigabatrin | Refractory complex partial seizures (rCPS) | Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia Information on weight based dosing, dosing in renal impairment, safety information and clinical trials | Labeling | - | - | B,P | - | Lundbeck LLC | 3/10/2013 | FALSE' |
| MESH:D006261 | 10/26/2013 | sabril | vigabatrin | Refractory complex partial seizures (rCPS) | Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia Information on weight based dosing, dosing in renal impairment, safety information and clinical trials | Labeling | - | - | B,P | - | Lundbeck LLC | 3/10/2013 | FALSE' |
| MESH:D006261 | 03/20/2014 | baraclude | entecavir | Treatment of chronic hepatitis B virus (HBV) infection | Approved for use in pediatric patients 2 years and older Safety and effectiveness have not been established in pediatric patients less than 2 years. Use in this age group has not been evaluated because treatment of HBV in this age group is rarely required There are limited data available on the use of Baraclude in lamivudine-experienced pediatric patients Adverse reactions in clinical trials were similar to those observed in adults Information on dosing in pediatric patients 2 years and weighing at least 10 kg, adverse reactions, PK parameters and clinical trials New dosage form | Labeling | - | - | B,P | - | Bristol-Myers Squibb | - | FALSE' |
| MESH:D006261 | 03/20/2014 | baraclude | entecavir | Treatment of chronic hepatitis B virus (HBV) infection | Approved for use in pediatric patients 2 years and older Safety and effectiveness have not been established in pediatric patients less than 2 years. Use in this age group has not been evaluated because treatment of HBV in this age group is rarely required There are limited data available on the use of Baraclude in lamivudine-experienced pediatric patients Adverse reactions in clinical trials were similar to those observed in adults Information on dosing in pediatric patients 2 years and weighing at least 10 kg, adverse reactions, PK parameters and clinical trials New dosage form | Labeling | - | - | B,P | - | Bristol-Myers Squibb | - | FALSE' |
