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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 772
n = 705 with New Pediatric Studies; n = 67 with No New Pediatric Studies
BPCA only = 186; BPCA + PREA = 117; PREA only = 420; Rule = 49

Pediatric Labeling Changes as of January 30, 2019

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:  772
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
01/29/2019 Vfend voriconazole (1) Invasive aspergillosis (2) Candidemia and disseminated candidiasis in skin, abdomen, kidney, bladder wall, and wounds (3) Esophageal candidiasis (4) Serious infections caused by Scedosporium apiospermum and Fusarium species in patients intolerant of, or refractory to, other therapy. • Expanded indications down to 2 years; previously approved in 12 years and older. • Safety and effectiveness have been established in pediatric patients 2 years of age and older based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. A total of 105 pediatric patients aged 2 to less than 12 [N=26] and aged 12 to less than 18 [N=79] from two, non-comparative Phase 3 pediatric studies and eight adult therapeutic trials provided safety information for Vfend use in the pediatric population. • Safety and effectiveness in pediatric patients below the age of 2 years has not been established. Therefore, Vfend is not recommended for pediatric patients less than 2 years of age. • The frequency of phototoxicity reactions is higher in the pediatric population. Squamous cell carcinoma has been reported in patients who experience photosensitivity reactions. [INVALID]nt measures for photoprotection are warranted. Sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation. • A higher frequency of liver enzyme elevations was observed in the pediatric patients. Hepatic function and serum creatinine levels should be closely monitored in pediatric patients. • There have been postmarketing reports of pancreatitis in pediatric patients. • Information on dosing, adverse reactions, PK parameters, and clinical studies. • Postmarketing study Antifungal
01/25/2019 Zovirax acyclovir sodium Neonatal herpes virus infection (HSV) *New dose: Post Menstrual Age (PMA) of at least 34 Weeks: 20 mg/kg every 8 hours for 21 days. PMA of less than 34 Weeks: 20 mg/kg every 12 hours for 21 days. Previously approved dose: Birth to 3 months: 10 mg/kg every 8 hours for 10 days. *In an open-label clinical trial, Zovirax 20 mg/kg every 8 hours (60 mg/kg/day) was compared with 15 mg/kg every 8 hours (45 mg/kg/day) to neonates =28 days old with suspected HSV infection. In total, 88 neonates were enrolled in the trial and received IV acyclovir for 21 days. The mean gestational ages (GA) were 37.5 and 37.9 weeks for the 45-mg/kg/day and 60-mg/kg/day doses, respectively. The number of premature infants (=37 weeks GA) receiving 45 mg/kg/day and 60 mg/kg/day were 7 (54%) and 22 (33%), respectively. *Among 69 patients with proven systemic (disseminated or CNS) herpes infection, 57 were randomized to receive Zovirax (20 mg/kg every 8 hours) while the remaining 12 patients received a lower dose of Zovirax every 8 hours. *Overall, the mortality among patients treated with Zovirax 20 mg/kg every 8 hours was lower compared with patients who received a lower dose of Zovirax. *Information on dosing and clinical trial. *Off-patent written request. Antiviral
12/21/2018 VAXELIS Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine* Active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2, and 3), against invasive disease caused by Haemophilus influenzae type b and infection caused by all known subtypes of hepatitis B virus in children 6 weeks through 4 years of age See Package Insert for new information on biologics Preventive Vaccine
12/21/2018 Sprycel dasatinib Pediatric patients one year and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy *Safety and effectiveness of Sprycel in combination with chemotherapy have been demonstrated in pediatric patients one year and over with newly diagnosed Ph+ ALL. *Use in pediatric patients is supported by evidence from one pediatric study. There are no data in children under 1 year. *The safety profile in pediatric patients was comparable to that reported in studies in adults. *Monitor bone growth and development in pediatric patients. *Five patients with Ph+ ALL 2 to 10 years of age received at least one dose of SPRYCEL tablet dispersed in juice. The exposure for dispersed tablets was 36% lower as compared to intact tablets in pediatric patients. Due to the limited available clinical data, it is unclear whether dispersing Sprycel tablets significantly alters the safety and/or efficacy of Sprycel. *New indication. Antineoplastic
12/12/2018 Exjade; Jadenu deferasirox Transfusion-dependent anemia requiring chelation therapy due to iron overload *A trial conducted in treatment naïve pediatric patients, ages 2 years to less than 18 years with transfusional iron overload did not include a sufficient number of patients to provide additional meaningful information about the safety or compliance of the deferasirox oral tablet for suspension dosage form (Exjade) compared to the deferasirox granules dosage form (Jadenu Sprinkle). Iron chelator
12/11/2018 Viread tenofovir disoproxil fumarate Chronic hepatitis B (CHB) in pediatric patients 2 years and older weighing at least 10 kg *Safety and effectiveness in pediatric patients 2 years to less than 18 years of age is supported by data from two randomized trials in which Viread was administered to HBV-infected treatment-experienced patients. *Safety and effectiveness in chronic HBV-infected pediatric patients younger than 2 years and weighing less than 10 kg have not been established. *The effects of Viread-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in chronic HBV-infected pediatric patients 2 years and older are unknown. The long-term effect of lower spine and total body BMD on skeletal growth in pediatric patients 2 years and older, and in particular, the effects of long-duration exposure in younger children is unknown. *Information on dosing, adverse reactions, and clinical trials. *New indication. Antiviral
11/29/2018 Astagraf XL tacrolimus Prophylaxis of organ rejection in kidney transplant patients, in combination with other immunosuppressants. *Safety and effectiveness of Astagraf XL in de novo pediatric kidney transplant patients have been established. *Use in pediatric kidney transplant patients is based on adequate and well controlled studies of Astagraf XL in adult kidney transplant patients and supported by pharmacokinetic and safety data in pediatric transplant patients 4 years of age and older who are able to swallow capsules intact and Prograf (tacrolimus) capsules in adult and pediatric transplant patients. *A pharmacokinetic and safety study included 25 de novo pediatric kidney transplant patients, 4 to 15 years of age, randomized and treated with either Prograf (n=12) or Astagraf XL (n=13). *Another pharmacokinetic and safety study included 48 stable pediatric kidney transplant patients, 5 to 16 years of age, who were converted from a Prograf-based regimen to Astagraf XL. *Information on dosing, clinical trials, adverse reactions and PK parameters. *Postmarketing study. Immunologic agent
11/21/2018 Spy Agent Green Indocyanine green Visualization of vessels, blood flow and tissue perfusion before, during, and after various surgical procedures, including minimally invasive surgeries and visualization of extrahepatic biliary ducts *Use for visualization of vessels, blood flow and tissue perfusion has been established in pediatric patients one month and older. *Pediatric use for visualization of vessels, blood flow and tissue perfusion is supported by published data in 49 pediatric patients who received indocyanine green for assessment of blood flow and tissue perfusion in cardiovascular, vascular and plastic, micro and reconstructive procedures, and by clinical trials in adults. *Use for visualization of extrahepatic biliary ducts has been established in pediatric patients aged 12 to 17 years. *Pediatric use for visualization of extrahepatic biliary ducts is supported by clinical trials in adults in addition to clinical use in pediatric patients. *Use of indocyanine green for visualization of extrahepatic biliary ducts has not been established in pediatric patients less 12 years of age. *Safety and efficacy of indocyanine green for visualization of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine tumors has not been established in pediatric patients. *Information on dosing. *New indication and a new route of administration. Medical imaging
11/09/2018 ORALAIR Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract* ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age. See Package Insert for new information on biologics Antiallergy
10/26/2018 Xyrem sodium oxybate Treatment of cataplexy or excessive daytime sleepiness to pediatric patients 7 years of age and older with narcolepsy *Safety and effectiveness in the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years and older with narcolepsy have been established in a double-blind, placebo-controlled, randomized-withdrawal study. *Safety and effectiveness in pediatric patients below the age of 7 years have not been established. *The adverse reaction profile in the pediatric clinical trial was similar to that seen in the adult clinical trial program. *In the pediatric clinical trial with Xyrem administration in patients with narcolepsy, serious adverse reactions of central sleep apnea and oxygen desaturation; suicidal ideation in one patient; neuropsychiatric reactions including acute psychosis, confusion, and anxiety; and parasomnias, including sleepwalking, have been reported. *Information on dosing, adverse reactions, clinical trial and PK parameters. *Postmarketing study. CNS Depressant
10/24/2018 Xofluza baloxavir marboxil Treatment of acute uncomplicated influenza in patients 12 years and older who have been symptomatic for no more than 48 hours *Safety and effectiveness for the treatment of influenza have been established in adults and pediatric patients 12 years and older weighing at least 40 kg. *Safety and effectiveness have not been established in pediatric patients less than 12 years. *Use in pediatric patients 12 years and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial in which 118 adolescents were randomized to receive either Xofluza (N=80) or placebo (N=38). The median time to alleviation of symptoms in adolescent subjects was 54 hours compared to 93 hours for subjects who received placebo. *Adverse reactions reported in adolescents were similar to those reported in adults. *Information on dosing, adverse reactions, clinical trial and PK parameters in adults and pediatric patients 12 years and older. *New drug. Antiviral
10/19/2018 Dupixent dupilumab Add-on maintenance treatment in patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma *Approved for use in adults and pediatric patients 12 years and older. *A total of 107 adolescents aged 12 to 17 years with moderate to severe asthma were enrolled in the clinical trial. *Not indicated for relief of acute bronchospasm or status asthmaticus. *Safety and efficacy in pediatric patients less than 12 years with asthma have not been established. *Safety and efficacy in pediatric patients (<18 years of age) with atopic dermatitis have not been established. *Dupilumab exposure was higher in adolescent patients than that in adults at the respective dose level which was mainly accounted for by difference in body weight. *The adverse event profile in adolescents was generally similar to the adults. *Information on dosage and administration, PK parameters, clinical trial. *New indication, new dupilumab strength. Antiasthmatic
10/04/2018 Lithium lithium Monotherapy treatment of acute manic or mixed episodes of bipolar I disorder and maintenance monotherapy of bipolar I disorder in pediatric patients ages 7 to 17 years *Safety and effectiveness for monotherapy treatment of acute manic or mixed episodes of bipolar I disorder and maintenance monotherapy of bipolar I disorder in pediatric patients ages 7 to 17 years have been established in a clinical trial of 8 weeks in duration followed by a 28-week randomized withdrawal phase. *Safety and effectiveness of lithium has not been established in pediatric patients less than 7 years of age with bipolar I disorder. *Common adverse reactions in pediatric patients 7 to 17 years included nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision. *Information on dosing, PK parameters and clinical trials. Mood-stabilizing agent
10/01/2018 Seysara sarecycline Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older *Safety and effectiveness have been established in adult and pediatric patients 9 years and older in two 12-week multicenter, randomized, double-blind, placebo-controlled studies in a total of 2002 patients. *Safety and effectiveness in pediatric patients below the age of 9 years has not been established. *Use of tetracycline-class antibiotics below the age of 8 is not recommended due to the potential for tooth discoloration. *Information on Pk parameters, and clinical trials in adults and pediatric patients 9 and older. *New drug. Antiacne, topical
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 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
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
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

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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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