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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 759
n = 692 with New Pediatric Studies; n = 67 with No New Pediatric Studies
BPCA only = 182; BPCA + PREA = 113; PREA only = 415; Rule = 49

Pediatric Labeling Changes as of September 30, 2018

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, press the pediatric labeling date in the first column of the database to reveal the additional information. To view all records in the database, press 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 press 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:  759
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
09/28/2018 Xolair omalizumab Postmarketing study *New 75 mg and 150 mg liquid prefilled syringes were approved to treat patients 6 years and older with moderate to severe asthma and to treat patients 12 years and older with chronic idiopathic urticaria. *New dosage form. Antiasthmatic; antiallergy
09/27/2018 Fycompa perampanel Treatment of partial onset seizures (POS), with or without secondarily generalized seizures in patients 4 years and older *Expanded the POS indication to include pediatric patients 4 to less than 12 years; previously approved for use in pediatric patients 12 years and older. *Safety and effectiveness for the POS indication have been not been established in pediatric patients less than 4 years. *Postmarketing study. anticonvulsant
09/27/2018 Promacta for oral suspension eltrombopag Postmarketing study *A new 12.5 mg Powder for Oral Suspension was approved. *Postmarketing study.
09/12/2018 Actemra tocilizumab Systemic juvenile idiopathic arthritis in pediatric patients 2 through 17 years – Subcutaneous *Approved new subcutaneous dosing and administration for the active systemic juvenile idiopathic arthritis in patients 2 years of age and older. *Information on dosing, clinical trials. *Postmarketing study. Anti-inflammatory
09/12/2018 Botox onabotulinumtoxinA Prevention of headaches in adolescents with chronic migraine *Safety and effectiveness in patients below the age of 18 years have not been established. *In a 12-week, multicenter, double-blind, placebo-controlled clinical trial, 123 adolescent patients (ages 12 to below 18 years) with chronic migraine were randomized to receive Botox 74 Units, Botox 155 Units, or placebo, for one injection cycle. This trial did not establish the efficacy of Botox, compared with placebo, for the prophylaxis of headaches in adolescents with chronic migraine. *Postmarketing study. Antimigraine
08/29/2018 JIVI Antihemophilic Factor (Recombinant), PEGylated-aucl* Use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for: on demand treatment and control of bleeding episodes; perioperative management of bleeding; and routine prophylaxis to reduce the frequency of bleeding episodes See Package Insert for new information on biologics Antihemophilic Factor
08/22/2018 Altreno lotion tretinoin Topical treatment of acne vulgaris *Safety and effectiveness have been established in pediatric patients age 9 years to less than 17 years based on evidence from two multicenter, randomized, double-blind, 12-week trials and an open-label pharmacokinetic study. A total of 318 pediatric subjects aged 9 to less than 17 years received Altreno in the clinical studies. *Safety and effectiveness in pediatric patients below the age of 9 years have not been established. *Information clinical trials, PK parameters, and adverse reactions. *New dosage form. Antiacne, topical
08/15/2018 Prepopik for oral solution sodium picosulfate, magnesium oxide, and anhydrous citric acid Cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years and older *Safety and effectiveness have been established in pediatric patients 9 years and older. *Use in this age group is supported by evidence from adequate and well-controlled trials of Prepopik in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age. *Safety and effectiveness of Prepopik in pediatric patients less than 9 years of age have not been established. *The safety profile in this pediatric population was similar to that seen in adults. *Monitor for possible hypoglycemia in pediatric patients, as Prepopik has no caloric substrate. *Information on adverse reactions, and clinical trial. *Postmarketing study. Osmotic laxative
08/10/2018 Annovera segesterone acetate and ethinyl estradiol vaginal system Prevention of pregnancy *Safety and efficacy of have been established in women of reproductive age. *Efficacy is expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. *Use before menarche is not indicated. *New drug. Contraceptive
08/08/2018 Jornay PM methylphenidate Attention Deficit Hyperactivity Disorder *Safety and effectiveness have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical studies in pediatric patients 6 to 12 years, pharmacokinetic data in adults, and safety information from other methylphenidate-containing products. *Safety and effectiveness in pediatric patients less than 6 years have not been established. *The long-term efficacy of methylphenidate in pediatric patients has not been established. *Growth should be monitored during treatment with stimulants, including JORNAY PM. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted. *Information on dosing, adverse reactions, clinical trials. *New dosage form. CNS Stimulant
08/03/2018 Nuvessa metronidazole Bacterial vaginosis *Safety and effectiveness have been established in pediatric patients 12 years and older. *Use in this age group of patients 12 to less than 18 years is supported by evidence from a multicenter, open-label safety and tolerability study in 60 pediatric patients with bacterial vaginosis and, evidence from adequate and well-controlled studies in adult women. *Safety and effectiveness in pediatric patients below the age of 12 years have not been established. *Safety was similar to that observed in adults. *Information on adverse reactions and clinical trial. *Postmarketing study. Antibiotic, topical
08/02/2018 PANZYGA Immune Globulin Intravenous, human-ifas* Indicated for 1) Primary humoral immunodeficiency (PI) in patients 2 years of age and older 2) Chronic immune thrombocytopenic purpura (ITP) in adults See Package Insert for new information on biologics Immunologic agent
07/31/2018 Granix injection tbo-filgrastim Reduce the duration of severe neutropenia in pediatric patients 1 month and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia *Safety and effectiveness have been established for pediatric patients 1 month to < 17 years old (no data for the age group < 1 month old). * Use in these age groups is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetics data from a single-arm trial of 50 pediatric patients with solid tumors treated with Granix for chemotherapy-induced neutropenia. *The safety profile in the pediatric population is similar to those observed in adults. *Information on adverse reactions, PK parameters, and clinical trial. *Postmarketing study. Leukocyte growth factor
07/30/2018 Kerydin topical solution tavaborole Topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes *Safety and efficacy were established in patients 6 years of age and older. *Use in these age groups is supported by evidence from adequate and well-controlled studies of Kerydin in adults with additional data from an open-label pharmacokinetics study of tavaborole in pediatric patients 12 years to less than 17 years old. *Information on PK parameters. *Postmarketing study. Antifungal, topical
07/20/2018 Lotemax loteprednol etabonate ophthalmic gel Treatment of postoperative inflammation and pain following ocular surgery *Safety and effectiveness have been established in the pediatric population. *Use in this population is supported by evidence from adequate and well-controlled trials of Lotemax in adults with additional data from a safety and efficacy trial in pediatric patients from birth to 11 years. *Information on clinical study. *Postmarketing study. Anti-inflammatory, topical
07/16/2018 Intelence etravirine Treatment of HIV-1 infection in patients 2 years to less than 6 years of age weighing at least 10 kg *Expanded the patient population to include pediatric patients 2 years to less than 6 years weighing at least 10 kg; previously approved in pediatric patients 6 years and older. *Use in pediatric patients 2 years to less than 6 years of age is supported by evidence from adequate and well-controlled studies in adults with additional data from a study in 20 pediatric patients 2 years to less than 6 years. *Treatment is not recommended in pediatric patients less than 2 years. *The pharmacokinetics and dose of etravirine in pediatric patients less than 2 years have not been established. *Safety was similar to that observed in adults. *Information on adverse drug reactions, pediatric trial. *Postmarketing study. Antiviral
06/29/2018 Yondelis injection trabectedin Pediatric histotypes of sarcoma *Safety and effectiveness in pediatric patients have not been established. *Safety (n=61) and efficacy (n=58) were assessed across five open-label studies in pediatric patients (aged 2 to less than 17 years) with pediatric histotypes of sarcoma. *No new safety signals were observed in pediatric patients across these studies. *Pharmacokinetic parameters in 17 pediatric patients (aged 3 to 17 years) were within the range of values previously observed in adults given the same dose per body surface area. Antineoplastic
06/28/2018 Qbrexza cloth glycopyrronium Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older *Safety, effectiveness and pharmacokinetics of Qbrexza have been established in pediatric patients age 9 years and older. *Use in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 4-week trials which included 34 pediatric subjects 9 years and older. *Safety and effectiveness have not been established in pediatric patients less than 9 years of age. *Information on dosing, adverse reactions, clinical trials. *New dosage form.
06/15/2018 LymePak doxycycline hyclate Treatment of early Lyme disease due to Borrelia burgdorferi in adults and pediatric patients 8 years of age and older weighing 45 kg and above *Safety and efficacy have been established in pediatric patients 8 years and older, weighing 45 kg and greater. *Because of the effects of the tetracycline-class of drugs on tooth development, bone development, and growth, use of LymePak in pediatric patients younger than 8 years of age, weighing less than 45 kg is not recommended. *New indication. Antibiotic
06/07/2018 Mircera Methoxy Polyethylene Glycol-Epoetin Beta Anemia associated with chronic kidney disease (CKD) in pediatric patients 5 to 17 years of age on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA *Safety and effectiveness of Mircera for the treatment of anemia due to CKD have been established in pediatric patients 5 to 17 years on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA. *The use of Mircera in this pediatric age group is supported by evidence from adequate and well-controlled studies of Mircera in adults and a dose-finding study in 64 pediatric patients 5 to 17 years. *Safety and effectiveness of Mircera have not been established in patients less than 5 years of age. *The safety and effectiveness of Mircera have not been established in pediatric patients of any age for subcutaneous administration; for treatment of anemia in patients with CKD on peritoneal dialysis; for treatment of anemia in patients with CKD who are not yet on dialysis; and for patients whose hemoglobin level has not been previously stabilized by treatment with an ESA. *Administer Mircera only intravenously in pediatric patients. *The adverse reaction profile was similar to those observed in adults. *Information on dosing, adverse reactions, PK parameters and clinical trial. *New indication. Hematopoietic
05/17/2018 Arnuity Ellipta fluticasone furoate Maintenance treatment of asthma in pediatric patients ages 5 through 11 years *Safety and efficacy of in pediatric patients with asthma aged 5 to 11 years have been established in 3 clinical trials. *In those trials, 234 subjects were administered Arnuity Ellipta 50 mcg once daily. Patients aged 5 to 11 years demonstrated safety and efficacy results similar to those observed in subjects aged 12 years and older. *Safety and efficacy have not been established in pediatric patients aged younger than 5 years. *Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents. *Information on dosing, adverse reactions, PK parameters, and clinical trials. Antiasthmatic
05/11/2018 Actemra tocilizumab Treatment of polyarticular juvenile idiopathic arthritis (PJIA) and Systemic Juvenile Idiopathic Arthritis (SJIA) *PJIA - Subcutaneous Use: Actemra by subcutaneous use is indicated for the treatment of pediatric patients with active PJIA in patients 2 years of age and older. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. *Subcutaneous administration has not been studied in SJIA pediatric patients. *SJIA – Intravenous Use: A multi-center, open-label, single arm study to evaluate the PK, safety and exploratory PD and efficacy of Actemra over 12-weeks in SJIA patients (N=11) under 2 years of age was conducted. *The primary PK endpoints at steady-state in this study were within the ranges of these parameters observed in patients with SJIA aged 2 to 17 years. *Safety and immunogenicity of Actemra for patients with SJIA under 2 years of age was assessed descriptively. *SAEs, AEs leading to discontinuation, and infectious AEs were reported by 27.3%, 36.4%, and 81.8% of patients. Six patients (54.5%) experienced hypersensitivity reactions. There were no cases of macrophage activation syndrome (MAS) based on the protocol-specified criteria, but 2 cases of suspected MAS based on Ravelli criteria. *Information on PK parameters, adverse reactions and clinical trial. *Postmarketing study.
05/11/2018 Gilenya fingolimod Treatment of relapsing forms of multiple sclerosis to include pediatric patients 10 years of age and above *Safety and effectiveness for the treatment of relapsing forms of multiple sclerosis in pediatric patients 10 to less than 18 years were established in one randomized, double-blind clinical study in 215 patients. *Safety and effectiveness in pediatric patients below the age of 10 years have not been established. *Safety in pediatric patients was similar to that observed in adult patients. *In the pediatric study, cases of seizures were reported in 5.6% of Gilenya treated patients and 0.9% of interferon beta-1a treated patients. *It is recommended that pediatric patients if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating Gilenya therapy. *Information on dosing, dosing in pediatric patients with renal impairment, PK parameters, adverse reactions, and clinical trial. *Postmarking study.
05/10/2018 Briviact brivaracetam Treatment of partial onset seizures (POS) to include patients 4 years to less than 16 years of age *Safety and effectiveness of Briviact tablets and oral solution have been established in pediatric patients 4 years to less than 16 years. *Use in these age groups is supported by evidence from adequate and well-controlled studies of Briviact in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 149 pediatric patients 4 years to less than 16 years. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Safety of Briviact injection in pediatric patients has not been established. *Adverse reactions, including psychiatric adverse reactions, were observed in open-label pediatric trials and were generally similar to those observed in adults. *Information on dosing, dosing in pediatric patients with hepatic impairment, PK parameters, adverse reactions, and clinical trial. *Postmarketing study. Anticonvulsant
05/03/2018 Lyrica pregabalin Adjunctive therapy in the treatment of partial onset seizures (POS) in pediatric patients 4 years to 16 years of age *Safety and effectiveness as adjunctive treatment for POS in pediatric patients 4 to less than 17 years of age have been established in a 12-week, double-blind, placebo-controlled trial (n = 295). *Safety and effectiveness in patients less than 4 years of age have not been established. *In the trial in pediatric patients for the treatment of partial onset seizures, somnolence was experienced by 21% of Lyrica-treated patients compared to 14% of placebo-treated patients, and occurred more frequently at higher doses. *The most common adverse reactions with Lyrica in the study were somnolence, weight increased, and increased appetite. *Information on dosing, adverse reactions, PK parameters, and clinical trial. *Postmarketing study. Anticonvulsant
04/30/2018 Amitiza lubiprostone Pediatric Functional Constipation (PFC) *Safety and effectiveness have not been established in pediatric patients less than 6 years. *Effectiveness has not been established in pediatric patients 6 years and older. Efficacy was not demonstrated for the treatment of PFC in a 12 week, randomized, double-blind, placebo controlled trial conducted in 606 patients 6 to 17 years with PFC comparing Amitiza to placebo. *Adverse reactions were similar to those reported in adults. *Information on clinical trial. *Postmarketing study.
04/03/2018 Emend Injection fosaprepitant Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) in pediatric patients 6 months and older *Safety and effectiveness of a single dose regimen of Emend for injection and a 3-day IV/oral/oral Emend regimen have been established in pediatric patients 6 months to 17 years. *Use in this age group is supported by evidence from adequate and well-controlled studies of Emend for injection in adults, with additional safety, efficacy and pharmacokinetic data in pediatric patients 6 months to 17 years. Efficacy was also supported by data from an adequate and well-controlled study of a 3-day oral aprepitant regimen in pediatric patients 6 months to 17 years. *Safety and effectiveness of EMEND for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months of age. *Safety of Emend for injection administered on consecutive days has not been established in pediatric patients 6 months to 17 years for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC and MEC. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK parameters, adverse reactions and clinical trials. *Postmarketing study. Antiemetic
03/22/2018 Symfi efavirenz, lamivudine and tenofovir disoproxil fumarate Treatment of HIV-1 infection in adult and pediatric patients weighing at least 40 kg *Safety and effectiveness of Symfi as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 40 kg have been established based on clinical studies using the individual components (efavirenz, lamivudine, and tenofovir disoproxil fumarate). *New drug. Antiviral
03/05/2018 Latuda lurasidone hydrochloride Treatment of children and adolescents with major depressive episodes associated with bipolar I disorder *Safety and effectiveness for the treatment of bipolar depression in pediatric patients 10 to 17 years was established in a 6-week, placebo-controlled clinical study in 347 pediatric patients. *Safety and effectiveness have not been established in pediatric patients less than 10 years of age with bipolar depression. *In the 6-week, placebo-controlled bipolar depression study in pediatric patients 10 to 17 years, somnolence was reported by 11.4% (20/175) of patients treated with Latuda compared to 5.8% (10/172) of placebo treated patients. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study. Antipsychotic
03/02/2018 Otiprio Otic Suspension ciprofloxacin Treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus *Safety and effectiveness for the treatment of acute otitis externa was established in 67 pediatric patients (3 through 17 years of age) who participated in the Phase 3 trial; 57% of patients were 3 through 11 years of age and 43% of patients were 12 through 17 years of age. *Safety and effectiveness in infants below 6 months of age have not been established. *The adverse reactions in pediatric patients were similar to those observed in adults. *Information on clinical trial. *New indication. Antibiotic, topical
02/28/2018 Cimduo lamivudine and tenofovir disoproxil fumarate Treatment of HIV-1 infection in adult and pediatric patients weighing at least 35 kg *Safety and effectiveness as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 35 kg have been established based on clinical studies using the individual components. *Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue CIMDUO as clinically appropriate. *New drug. Antiviral
02/20/2018 Luzu cream luliconazole Tinea pedis and tinea cruris *Safety and effectiveness in pediatric patients 12 to <18 years with tinea pedis and tinea cruris have been established by evidence from well-controlled trials in adult and pediatric patients and a pharmacokinetic study in pediatric patients. *Safety and effectiveness in pediatric patients 2 to <18 years of age with tinea corporis have been established by evidence from a well-controlled trial in pediatric patients. *Postmarketing study. Antifungal, topical
02/15/2018 Cialis tadalafil Duchenne muscular dystrophy *Not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established. *A randomized, double-blind, placebo-controlled trial in pediatric patients 7 to 14 years with Duchenne muscular dystrophy failed to demonstrate any benefit of treatment on a range of assessments of muscle strength and performance. Peripheral Vasodilator
02/06/2018 Pristiq desvenlafaxine Major Depressive Disorder (MDD) *Safety and effectiveness have not been established in pediatric patients for the treatment of MDD. *Efficacy was not demonstrated in two adequate and well controlled, 8-week, randomized, double-blind, placebo-controlled, parallel group studies conducted in 587 patients 7 to 17 years for the treatment of MDD. *Antidepressants, such as Pristiq, increase the risk of suicidal thoughts and behaviors in pediatric patients. *Pristiq was associated with a decrease in body weight in placebo-controlled trials in pediatric patients with MDD. The incidence of weight loss was 22%, 14%, and 7% for patients treated with low dose Pristiq, high dose Pristiq, and placebo, respectively. *The risks associated with longer term Pristiq use were assessed in 6-month, open-label extension studies in pediatric patients 7 to 17 years with MDD. *Postmarketing study. Antidepressant
02/05/2018 Symfi Lo efavirenz, lamivudine and tenofovir disoproxil fumarate HIV-1 infection in adult and pediatric patients weighing at least 35 kg *Safety and effectiveness of Symfi Lo as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 35 kg have been established based on clinical studies using the individual components. *New dosage form. Antiviral
01/11/2018 Fluarix Quadrivalent Influenza Vaccine* For active immunization of persons 6 months and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine See Package Insert for new information on biologics Preventive Vaccine
12/26/2017 Draximage DTPA Technetium Tc99m Pentetate Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation and for renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate *Indicated in pediatric patients ages birth to less than 17 years of age. *Pediatric use is supported by evidence from controlled studies in adults and dosing and safety are based on clinical experience. *The radiation risk of Technetium Tc 99m pentetate is greater in pediatric patients than adults. *New route of administration and new indication. Medical imaging
12/22/2017 Procysbi cysteamine bitartrate Treatment-naïve nephropathic cystinosis patients 1 year and older *Expanded the indication to patients age 1 year and older; previously approved in 2 years and older. * Safety and effectiveness in pediatric patients under 1 years of age have not been established. *Adverse reactions in pediatric patients were similar to those in adults. *Information on dosing, PK parameters, and clinical trial.
12/22/2017 Lumify Ophthalmic Solution brimonidine tartrate Relief of redness of the eye due to minor eye irritations * Approved for use in adults and pediatric patients 5 years and older. *New formulation. Ophthalmologic hypotensive
12/11/2017 Xepi ozenoxacin Impetigo in adults, adolescents and children 2 months and older *Safety and effectiveness in the treatment of impetigo have been established in pediatric patients 2 months to 17 years of age. *Use in pediatric patients 2 months to 17 years of age is supported by evidence from adequate and well-controlled studies in which 251 pediatric patients received at least one dose of Xepi. *Safety and effectiveness in pediatric patients younger than 2 months of age have not been established. *Information on adverse reactions and clinical trials. Antibiotic, topical
12/08/2017 Omidria intraocular solution phenylephrine and ketorolac Prevention of intraoperative miosis and reduction of postoperative pain in patients who have undergone cataract surgery *Safety and effectiveness have been established in the pediatric population from neonates to adolescents (birth to younger than 17 years). * Use in this population is supported by evidence from adequate and well-controlled studies of Omidria in adults with additional data from a single active-controlled safety study in pediatric patients up to 3 years old. *The safety profile in children was similar to that observed in adults. *Information on adverse reactions and clinical trials. Analgesic, topical
12/06/2017 Jakafi ruxolitinib Relapsed or refractory solid tumors, leukemias or myeloproliferative neoplasms *The safety and effectiveness of Jakafi in pediatric patients have not been established. *Jakafi was evaluated in a single-arm, dose-escalation study in 27 pediatric patients with relapsed or refractory solid tumors and 20 with leukemias or myeloproliferative neoplasms. *A protocol-defined maximal tolerated dose was not observed, but since few patients were treated for multiple cycles, tolerability with continued use was not assessed adequately to establish a recommended Phase 2 dose. *The safety profile in children was similar to that observed in adults. *Information on dosing, and clinical trial. Hematology
11/22/2017 Isentress oral suspension raltegravir HIV exposed neonates ages 0-4 weeks and weighing at least 2 kg *Safety and pharmacokinetics of Isentress oral suspension were evaluated in 42 full-term HIV-1 exposed neonates at high risk of acquiring HIV-1 infection in a Phase 1, open-label, multicenter clinical study. *Not recommended in pre-term neonates or in pediatric patients weighing less than 2 kg. *Safety profile was similar to that observed in adults. *Postmarketing study. Antiviral
11/21/2017 Triumeq abacavir, dolutegravir, and lamivudine Treatment of HIV-1 infection in patients weighing at least 40 kg *Clinical data supporting use of Triumeq in HIV-1 infected pediatric patients weighing at least 40 kg is derived from previously conducted pediatric trials using the individual components of Triumeq. *Triumeq is a fixed-dose combination tablet which cannot be adjusted for patients weighing less than 40 kg. *Postmarketing study. Antiviral
11/14/2017 Fasenra benralizumab Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype *Indicated in pediatric patients 12 years and older. *There were 108 adolescents aged 12 to 17 with asthma enrolled in the two Phase 3 exacerbation trials. *Safety and efficacy in patients younger than 12 years of age has not been established. *Adverse reactions were similar to those observed in adults. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *New drug. Antiasthmatic
11/14/2017 Tekturna aliskiren Treatment of hypertension in adults and children 6 years of age and older *Approved for use in adults and children 6 years and older. *Tekturna was evaluated in two randomized, double-blind clinical studies in pediatric patients 6 to 17 years of age. *Tekturna is contraindicated in children less than 2 years of age. Tekturna should not be used in children 2 to less than 6 years or in children who weigh less than 20 kg. *Preclinical studies indicate a potential for substantial increase in exposure to aliskiren in pediatric patients. *Information on administration of oral pellets. Do not chew or crush the contents of the capsules. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK, and clinical trial. *Postmarketing study. Antihypertensive
11/03/2017 Vimpat lacosamide Treatment of partial-onset seizures to patients 4 years of age and older *Expanded the use of Vimpat tablets and oral solution for the treatment of partial-onset seizures to patients 4 years of age and older. *Use in this age group is supported by evidence from adequate and well-controlled studies in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 to less than 17 years of age. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Safety of Vimpat injection in pediatric patients has not been established. *In pediatric patients 4 years to less than 17 years of age, the recommended dosing regimen is based on body weight and is only recommended to be administered orally. *Adverse reactions were similar to those observed in adults. *Information on PK parameters, dosing, adverse reactions. *Postmarketing study. Anticonvulsant
10/13/2017 Pegays Pegfilgrastim Treatment of non-cirrhotic pediatric patients 3 years of age and older with HBeAg-positive Chronic Hepatitis B virus infection *Use for the treatment of pediatric patients 3 to 17 years of age with CHB is based on one clinical trial in 161 previously untreated CHB subjects 3 to 17 years of age of whom 111 were assigned to treatment with PEGASYS. *PEGASYS has not been studied in pediatric CHB patients with liver cirrhosis and the safety and efficacy in pediatric patients with CHB below the age of 3 years have not been established. *Growth inhibition was observed in CHB pediatric patients 3 to 17 years of age during therapy with PEGASYS lasting up to 48 weeks. *Adverse reactions observed in 3-17 years were similar to adults. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study Antiviral
10/13/2017 Butrans transdermal system buprenorphine Treatment of moderate-to severe chronic pain requiring continuous, around-the clock opioid treatment for an extended period of time *Safety and efficacy in patients under 18 years of age have not been established. *Butrans has been evaluated in an open-label clinical trial in pediatric patients. However, definitive conclusions are not possible because of the small sample size. *Postmarketing study. Analgesic
10/13/2017 Stelara ustekinumab Psoriasis treatment of adolescent patients ages 12-17 years *Safety and effectiveness of have been established in pediatric subjects 12 to 17 years old with moderate to severe plaque psoriasis. Use of in this age group is supported by evidence from a multicenter, randomized, 60-week trial that included a 12-week, double-blind, placebo-controlled, parallel-group portion, in 110 pediatric subjects 12 years and older. *Safety and effectiveness for pediatric patients less than 12 years of age have not been established. *Adverse reactions observed in 12-17 years were similar to adults. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study Monoclonal antibody

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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. Note: Drugs with *** had a pediatric labeling change in response to BPCA after the Written Request expired.

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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