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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 701
n = 634 with New Pediatric Studies; n = 67 with No New Pediatric Studies
BPCA only = 178; BPCA + PREA = 97; PREA only = 375; Rule = 49; None = 1

Pediatric Labeling Changes as of July 31, 2017

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:  701
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
07/26/2017 Fycompa perampanel Monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older *Expanded the indication to include use as monotherapy for the treatment POS in patients with epilepsy aged 12 years and older; previously approved for use as adjunctive therapy. *New indication. Anticonvulsant
07/06/2017 Vimovo naproxen/esomeprazole magnesium Juvenile idiopathic arthritis (JIA) in adolescent patients 12 years of age and older weighing at least 38 kg *Safety and effectiveness have been established in adolescent patients 12 years and older weighing at least 38 kg for the symptomatic relief of JIA and to decrease the risk of developing naproxen-associated gastric ulcers. *Use in this age group is based on extrapolation of adequate and well-controlled studies in adults and supported by a 6 month safety study including pharmacokinetic assessment of naproxen and esomeprazole magnesium in 36 adolescent patients with JIA. *The safety profile in adolescent patients with JIA was similar to adults with RA. *Safety and effectiveness in pediatric patients less than 12 years or less than 38 kg with JIA have not been established. *Information on recommended dosing, and PK. *New indication. Anti-inflammatory
06/22/2017 Simponi golimumab Active polyarticular juvenile idiopathic arthritis *Effectiveness in pediatric patients less than 18 years of age has not been established. *Safety and efficacy were evaluated in a multicenter, placebo-controlled, double-blind, randomized-withdrawal, parallel group study in 173 children 2 to 17 years of age with active polyarticular juvenile idiopathic arthritis (pJIA) despite treatment with MTX for at least 3 months. *Adverse reactions were similar to those observed in adults. *Information dosing, and clinical trial. *Postmarketing study. Anti-inflammatory
06/20/2017 Mydayis mixed salts of a single-entity amphetamine Treatment of Attention Deficit Hyperactivity Disorder (ADHD) *Safety and effectiveness in pediatric patients with ADHD ages 13 to 17 years have been established in two placebo-controlled clinical studies. *Safety and effectiveness have not been established in pediatric patients ages 12 years and younger. *In clinical trials, pediatric patients 6 to 12 years of age experienced higher rates of adverse reactions in some cases compared to patients 13 years and older, including higher rates of insomnia (30% versus 8%) and appetite decreased (43% versus 22%). *Amphetamine systemic exposures (both d- and l-) in patients 6 to 12 years following a single dose were higher than those observed in adults at the same dose. *Information on PK parameters, adverse reactions and clinical trials. *New dosage form. CNS Stimulant
06/19/2017 Cotempla XR-ODT methylphenidate Treatment of Attention Deficit Hyperactivity Disorder (ADHD) *Safety and effectiveness have been established in pediatric patients 6 to 17 years in one adequate and well-controlled study in pediatric patients 6 to 12 years, pharmacokinetic data in adolescents, and safety information from other methylphenidate-containing products. *Safety and effectiveness in pediatric patients below 6 years of age 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. *Information on dosing, adverse reactions, and clinical trial. *New dosage form. CNS Stimulant
06/15/2017 Calcium Gluconate calcium gluconate Treatment of acute symptomatic hypocalcemia *Safety and effectiveness have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia. *Pediatric approval is not based on adequate and well-controlled clinical studies. Safety and dosing recommendations in pediatric patients are based on published literature and clinical experience. *Concomitant use of ceftriaxone and calcium gluconate Injection is contraindicated in neonates (28 days or younger) due to reports of fatal outcomes associated with the presence of lung and kidney ceftriaxone-calcium precipitates. In patients older than 28 days, ceftriaxone and calcium gluconate Injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid. *This product contains up to 400 mcg/L aluminum which may be toxic, particularly for premature neonates due to immature renal function. Parenteral administration of aluminum greater than 4 to 5 mcg/kg/day is associated with central nervous system and bone toxicity. *New drug.
06/07/2017 FIBRYNA Fibrinogen (Human)* Treatment of acute bleeding episodes in adults and adolescents = 12 years of age with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia See Package Insert for new information on biologics
05/31/2017 Rebinyn Coagulation Factor IX (Recombinant), GlycoPEGylated* Approved for use in adults and children with hemophilia B for: (1) On-demand treatment and control of bleeding episodes; (2) Perioperative management of bleeding See Package Insert for new information on biologics
05/30/2017 Zerviate Ophthalmic Solution cetirizine Ocular itching associated with allergic conjunctivitis in patients 2 years of age and older *Safety and effectiveness have been established in pediatric patients two years of age and older. *Use in these pediatric patients is supported by evidence from adequate and well-controlled studies in pediatric and adult patients. *New dosage form. Antihistamine, topical
05/26/2017 Isentress HD raltegravir In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and in pediatric patients weighing at least 40 kg *New 600 mg film coated tablet approved for once daily use. *Isentress HD once daily has not been studied in pediatric patients. However population PK modeling and simulation support the use of 1200 mg (2 x 600 mg) once daily in pediatric patients weighing at least 40 kg. *New dosage form. Antiviral
05/23/2017 Sensipar cinacalcet Treatment of secondary HPT in pediatric patients with Chronic Kidney Disease on dialysis *Safety and efficacy for the pediatric population have not been established. *Use for the treatment of secondary HPT in pediatric patients with CKD on dialysis was evaluated in two randomized, controlled studies in 47 pediatric patients aged 6 years to less than 18 years and in one single-arm study in 17 pediatric patients aged 28 days to less than 6 years. *Dosing with Sensipar in pediatric study 1 was stopped because of a fatality in a Sensipar-treated individual who was noted to be severely hypocalcemic at the time of death. The cause of death was multifactorial and a contribution of Sensipar to the death could not be excluded. *Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with Sensipar, including in pediatric patients. *Pediatric studies did not establish a safe and effective Sensipar dosing regimen for the pediatric population. *Information on safety, and clinical trials.
05/17/2017 Jevtana cabazitaxel Solid tumors *Safety and effectiveness in pediatric patients have not been established. *Jevtana was evaluated in 39 pediatric patients (ages 3 to 18 years) receiving prophylactic granulocyte - colony stimulating factor. No objective responses were observed in 11 patients with refractory high grade glioma or diffuse intrinsic pontine glioma. One patient had a partial response among the 9 patients with ependymoma. *Infusion-related/hypersensitivity reactions were seen in 10 patients (26%). Three patients experienced serious adverse events of anaphylactic reaction. The incidence of infusion related/hypersensitivity reactions decreased with steroid premedication. *The most frequent treatment-emergent adverse events were similar to those reported in adults. *Information on safety, dosing, PK parameters, and clinical trials. Antineoplastic
04/07/2017 Sovaldi sofosbuvir In combination with ribavirin for the treatment of chronic hepatitis C virus genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis in pediatric patients 12 to 17 years of age or weighing at least 35 kg *Expanded the indication from adults to pediatric patients 12 years and older or weighing at least 35 kg. *Sovaldi was evaluated in an open-label clinical trial which included 50 patients 12 years of age and older. *Safety and efficacy have not been established in pediatric patients less than 12 years of age and weighing less than 35 kg with HCV genotype 2 or 3. Safety and efficacy have not been established in pediatric patients with HCV genotype 1 or 4. *Adverse reactions were similar to those observed in adults. *Information on dosing,clinical trial, and PK. Antiviral
04/07/2017 Harvoni ledipasvir and sofosbuvir Treatment of chronic hepatitis C virus genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis in pediatric patients 12 years of age and older or weighing at least 35 kg *Expanded the indication from adults to pediatric patients 12 years and older or weighing at least 35 kg. *Safety, pharmacokinetics, and efficacy for treatment of HCV genotype 1 infection in treatment-naïve and treatment-experienced pediatric patients 12 years of age and older without cirrhosis or with compensated cirrhosis have been established in an open-label, multicenter clinical trial. *Safety and efficacy have not been established in pediatric patients less than 12 years and weighing less than 35 kg, in pediatric patients with decompensated cirrhosis, or in pediatric liver transplant recipients. *Adverse reactions were similar to those observed in adults. *Information on dosing, clinical trial, and PK Antiviral
04/05/2017 Visipaque iodixanol 320 mgI/mL "Coronary computed tomography angiography (CCTA) to assist diagnostic evaluation of adults and pediatric patients 12 years and older with suspected coronary artery disease" *Approved for use for CCTA in adults and pediatric patients 12 years and older. *Safety and efficacy have not been established in pediatric patients less than 12 years for CCTA. *Pediatric patients at higher risk of experiencing an adverse reaction during and after administration of any contrast agent may include those with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, congestive heart failure, or a serum creatinine greater than 1.5 mg/dL. Pediatric patients with immature renal function or dehydration may be at increased risk for adverse events due to slower elimination of iodinated contrast agents. *Information on safety, and dosing. *New indication. Medical imaging
03/30/2017 Orencia abatacept Treatment of moderately to severely active Polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older *Approved for use in pJIA in pediatric patients 2 years and older as monotherapy or concominatly with methotrexate. *For pJIA, Orencia may be administered as an intraveneous infusion in 6 years and older or a subcutaneous injection in 2 years and older. Intraveneous dosing has not been studied in pediatric patients younger than 6 years of age. *Orencia with intravenous administration has not been studied in patients younger than 6 years of age. *Efficacy of Orencia for subcutaneous injection in children 2 to 17 years of age is based on pharmacokinetic exposure and extrapolation of established efficacy of intravenous Orencia in polyarticular JIA patients and subcutaneous Orencia in patients with RA. *Safety and efficacy of Orencia ClickJect autoinjector for subcutaneous injection have not been studied in patients under 18 years of age. *Safety and efficacy in pediatric patients for uses other than juvenile idiopathic arthritis have not been established. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, immunogenicity, dosing, clinical trials. *Postmarketing study. Anti-inflammatory
03/29/2017 Cubicin Injection daptomycin Complicated skin and skin structure infections (cSSSI) in pediatric patients 1 to 17 years of age *Safety and effectiveness in the treatment of cSSSI has been established in the age groups 1 to 17 years. Use in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and data from a safety, efficacy and PK study in pediatric patients 1 to 17 years of age with cSSSI. * Safety and effectiveness in pediatric patients below the age of one year have not been established. Avoid use of Cubicin in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems observed in neonatal dogs. * Not indicated in pediatric patients with renal impairment because dosage has not been established in these patients. * The safety profile in pediatric patients was similar to that observed in adult patients. * Information on dosing, administration, adverse reactions, PK, and clinical trial. * Postmarketing study. Antibiotic
03/21/2017 Ciloxan ophthalmic solution ciprofloxacin Bacterial conjunctivitis in pediatric patients less than 1 month old *Expanded the indication down to pediatric patients less than 1 year; previously approved for 1 year and older. *Information on clinical trial in pediatric patients birth to 31 days. Antibiotic, topical
03/21/2017 Zymar Ophthalmic Solution gatifloxacin Bacterial conjunctivitis in pediatric patients less than 1 month of age *Expanded the indication down to pediatric patients less than 1 year; previously approved for 1 year and older. *Information on clinical trial in pediatric patients birth to 31 days. Antibiotic, topical
03/14/2017 Vigamox Ophthalmic Solution moxifloxacin Bacterial conjunctivitis in pediatric patients less than 1 year of age *Expanded the indication down to pediatric patients less than 1 year; previously approved for 1 year and older. *Information on clinical trial in pediatric patients birth to 31 days. Antibiotic, topical
03/03/2017 Rubber Panel T.R.U.E. TEST Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test¿ An aid in the diagnosis of allergic contact dermatitis in persons 6 years of age and older whose history suggests sensitivity to one or more of the 5 substances included on the Rubber Panel T.R.U.E. TEST See Package Insert for new information on biologics
03/01/2017 Cerebyx fosphenytoin sodium Treatment of generalized tonic-clonic status epilepticus, for the prevention and treatment of seizures occurring during neurosurgery, and for short-term substitution for oral phenytoin in pediatric patients birth to less than 17 years of age *Approved for use in pediatric patients birth to less than 17 years. *Because rapid intravenous administration of Cerebyx increases the risk of adverse cardiovascular reactions, the rate of administration should not exceed 2 mg PE/kg/min ((or 150 mg PE/min, whichever is slower) in pediatric patients. * Intramuscular administration of Cerebyx should ordinarily not be used in pediatric patients. * Adverse reactions in pediatric patients were similar to those observed in adults. *Information on dosing, adverse reactions, and PK. Anticonvulsant
03/01/2017 Liquid E-Z-Paque barium sulfate Use in single contrast radiographic examinations of the esophagus, stomach, and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients *Efficacy in pediatric patients from birth to less than 17 years of age is based on successful opacification of the esophagus, stomach, and small bowel during single contrast radiographic procedures. * Safety and dosing recommendations in pediatric patients are based on clinical experience. * Contraindicated in pediatric patients with tracheo-esophageal fistula. * Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions. Monitor pediatric patients with cystic fibrosis or Hirschsprung disease for bowel obstruction after use. * Information on dosing. Medical Imaging
02/23/2017 RotaTeq Rotavirus Vaccine, Live, Oral, Pentavalent* Prevention of rotavirus gastroenteritis caused by types G1, G2, G3, G4, and G9 in infants 6 weeks to 32 weeks of age See Package Insert for new information on biologics Preventive Vaccine
02/15/2017 Spiriva Respimat Inhalation Spray tiotropium bromide Long-term, once-daily, maintenance treatment of asthma in patients 6 through 11 years of age *Expanded indication down to 6 years and older based on three clinical trials in patients 6 to 11 years; previously approved in 12 years and older. *The safety and efficacy have not been established in pediatric patients less than 6 years of age. *The safety of Spiriva Respimat delivered with a valved holding chamber with facemask once daily has been studied in pediatric patients with asthma aged 1 to 5 years who were on background treatment of at least Inhaled Corticosteroid in one placebo-controlled clinical trial of 12 weeks duration. *The adverse reaction profile was similar to that observed in adults and older pediatric patients. *Information on dosing, adverse reactions and clinical trials. *Postmarketing study. Antiasthmatic
01/28/2017 Vyvanse Chewable Tablet lisdexamfetamine Attention Deficit Hyperactivity Disorder in pediatric patients ages 6 to 17 years *New Vyvanse chewable tablets approved. Vyvanse chewable tablets must be chewed thoroughly before swallowing. *Vyvanse capsules can be substituted with Vyvanse chewable tablets on a unit per unit/ mg per mg basis (e.g., 30 mg capsules for 30 mg chewable tablet). *Information on pharmacokinetics. *New formulation. CNS Stimulant
01/27/2017 Symbicort Inhalation Aerosol budesonide/formoterol fumarate dihydrate Asthma in pediatric patients 6 to less than 12 years *Expanded indication down to 6 to less than12 years; previously approved down to pediatric patients 12 years and older. * Safety and effectiveness in asthma patients less than 6 years have not been established. *Safety profile in pediatric patients 6 to less than 12 years was similar to that observed in patients 12 years of age and older.*Information on dosing, adverse reactions, and clinical trials. *Postmarketing study. Antiasthmatic
01/27/2017 ArmonAir RespiClick fluticasone propionate Maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older *Approved for use in 12 years and older. *Safety and effectiveness in pediatric patients below the age of 12 years have not been established. *Inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity in adolescents. *Information on dosing, and adverse reactions and clinical trials in adults and pediatric patients 12 years and older. *New dosage form. Antiasthmatic
01/27/2017 Latuda lurasidone hydrochloride Treatment of schizophrenia in adolescents and irritability associated with autistic disorder in pediatric patients Schizophrenia *Safety and effectiveness for the treatment of schizophrenia in adolescents 13 to 17 years was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients. *In the short-term, placebo-controlled adolescent schizophrenia study, somnolence was reported by 14.5% (31/214) of patients treated with Latuda compared to 7.1% (8/112) of placebo patients. *In the short-term, placebo-controlled, study of schizophrenia in adolescents, the incidence of EPS, excluding events related to akathisia, for Latuda-treated patients was higher in the 40 mg (10%) and the 80 mg (7.7%) treatment groups vs. placebo (3.6%); and the incidence of akathisia-related events for Latuda-treated patients was 8.9% vs. 1.8% for placebo-treated patients. *The most common adverse reactions in adolescent patients treated with Latuda were somnolence, nausea, akathisia, extrapyramidal symptoms (non-akathisia, 40mg only), vomiting, and rhinorrhea/rhinitis (80mg only). Irritability Associated with Autistic Disorder *The effectiveness in pediatric patients for the treatment of irritability associated with autistic disorder has not been established. *Efficacy was not demonstrated in a 6-week study of 149 pediatric patients 6 to 17 years with irritability associated with autistic disorder. *Vomiting occurred at a higher rate than reported in other Latuda studies (4/49 or 8% for 20mg, 14/51 or 27% for 60mg, and 2/49 or 4% for placebo), particularly in children ages 6 to 12 (13 out of 18 patients on Latuda with vomiting). *Information on dosing, metabolic changes, adverse reactions and clinical trials. *Postmarketing study. Antipsychotic
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. Analgesic; Antipyretic
01/27/2017 Stribild elvitegravir, cobicistat, emtricitabine/tenofovir disoproxil fumarate HIV in pediatric patients 12 years of age and older weighing at least 35 kg *Expanded the indication to pediatric patients 12 years of age and older weighing at least 35 kg; previously approved in adults. *The PK, safety, and virologic and immunologic responses were evaluated in 50 treatment-naïve, HIV-1-infected subjects aged 12 to less than 18 years weighing at least 35 kg receiving Stribild through 48 weeks in an open-label trial. The safety and efficacy in these patients was similar to that in antiretroviral treatment-naïve adults. *Safety and effectiveness in pediatric patients less than 12 years of age or weighing less than 35 kg have not been established. *Clinical trials evaluating tenofovir DF in pediatric and adolescent patients were conducted. In HIV-1-infected subjects aged 2 years to less than 18 years, bone effects were similar to those observed in adult subjects and suggest increased bone turnover. Total body BMD gain was less in the tenofovir DF-treated HIV-1-infected pediatric subjects as compared to the control groups. In all pediatric trials, skeletal growth (height) appeared to be unaffected. *Information on clinical trials, adverse reactions, and PK parameters. *Postmarketing study. Antiviral
01/27/2017 AirDuo RespiClick fluticasone propionate/salmeterol "Maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older" *Approved for use in 12 years and older. *Safety and effectiveness in pediatric patients below the age of 12 years have not been established. *Inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity in adolescents. *Information on dosing, and adverse reactions and clinical trials in adults and pediatric patients 12 years and older. *New dosage form. Antiasthmatic
12/22/2016 ADYNOVATE Antihemophilic Factor (Recombinant), PEGylated* Treatment and control of bleeding episodes in adolescents and adults with hemophilia A. Routine prophylaxis to reduce the frequency of bleeding episodes in adolescents and adults with hemophilia A. See Package Insert for new information on biologics Antihemophilic Factor
12/22/2016 Lumason Sulfur Hexafluoride Lipid-Type A Microspheres Evaluation of suspected or known vesicoureteral reflux in pediatric patients *Effectiveness in pediatric patients has been established for use in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux from two published studies comprising a total of 411 pediatric patients. *Safety of intravesical use of Lumason was based on evaluation of published literature involving use of Lumason in over 6000 pediatric patients. No adverse reactions were reported. *Information on published studies. *New indication. Medical Imaging
12/22/2016 Lyrica pregabalin Fibromyalgia *Safety and efficacy in pediatric patients have not been established. *A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . *The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. *The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. *Postmarketing study. Antidepressant
12/16/2016 Ryzodeg 70/30 insulin degludec/insulin aspart Improve glycemic control in type 1 and type 2 diabetes mellitus in pediatric patients 1 year and older *Expanded indication from adults to pediatric patients 1 year and older. *Use in pediatric patients 1 year and older with type 1 and type 2 diabetes mellitus is supported by evidence from an adequate and well-controlled study and a pharmacokinetic study. Use in pediatric patients 1 year and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 1 year old. *In pediatric patients 1 year and older with switching from other insulin therapies, start Ryzodeg 70/30 at a reduced dose to minimize the risk of hypoglycemia. *In pediatric patients inject Ryzodeg 70/30 subcutaneously once daily with any main meal. *Not recommended for pediatric patients requiring less than 5 units of Ryzodeg 70/30 daily. *Adverse reactions similar to those observed in adults. *Information on dosing, PK, and clinical trials. *Postmarketing study. Antidiabetic
12/16/2016 Tresiba insulin degludec Improve glycemic control in type 1 and type 2 diabetes mellitus in pediatric patients 1 year and older *Expanded indication from adults to pediatric patients 1 year and older. *Use in pediatric patients 1 year and older with type 1 and type 2 diabetes mellitus is supported by evidence from an adequate and well-controlled study and a pharmacokinetic study. Use in pediatric patients 1 year and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 1 year old. *In pediatric patients 1 year and older with switching from other insulin therapies, start Ryzodeg 70/30 at a reduced dose to minimize the risk of hypoglycemia. *In pediatric patients inject Ryzodeg 70/30 subcutaneously once daily with any main meal. *Not recommended for pediatric patients requiring less than 5 units of Ryzodeg 70/30 daily. *Adverse reactions similar to those observed in adults. *Information on dosing, PK, and clinical trials. *Postmarketing study. Antidiabetic
12/14/2016 Eucrisa ointment crisaborole Mild to moderate atopic dermatitis in patients 2 years of age and older * Safety and effectiveness have been established in pediatric patients age 2 years and older for topical treatment of mild to moderate atopic dermatitis. * Use in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 28-day trials which included 1,313 pediatric patients 2 years and older. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. * Information on PK, adverse events in adults and children, and clinical trial. *New drug.
11/25/2016 Renvela sevelamer carbonate Control of serum phosphorus in children 6 years of age and older with chronic kidney disease on dialysis *Expanded the indication from adults to pediatric patients ages 6 years and older. *Renvela has not been studied in pediatric patients below 6 years of age. *Most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. *Information on starting dose and titration, adverse reactions and clinical trial. *Postmarketing study Phosphate binder
11/18/2016 FluLaval Influenza Virus Vaccine* Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine in persons aged 6 months and older See Package Insert for new information on biologics Preventive Vaccine
11/18/2016 FluLaval Quadrivalent Influenza Virus Vaccine* Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine in persons aged 6 months and older See Package Insert for new information on biologics Preventive Vaccine
11/11/2016 Naftin naftifine hydrochloride Tinea corporis in pediatric patients 2 years and older *Expanded the indication down to pediatric patients 2 years and older; previously approved in pediatric patients 12 years and older. *Safety and effectiveness in the treatment of tinea corporis in pediatric patients less than 2 years of age have not been established. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, pharmacokinetic parameters, and clinical trials. *Postmarketing study Antifungal, topical
11/04/2016 Enbrel etanercept Chronic moderate to severe plaque psoriasis (PsO ) in patient who are candidates for systemic therapy or phototherapy patients ages 4 to 17 years *Expanded the indication from adults to pediatric patients 4 to 17 years. *Enbrel has been studied in 211 pediatric patients with moderate to severe PsO aged 4 to 17 years. * Enbrel has not been studied in children less than 4 years of age with PsO. * Adverse events were similar to those observed in adults. *Information on dosing, PK, adverse reactions, and clinical trial. * New indication. Immunosuppressant
11/04/2016 Selzentry maraviroc Treatment of only CCR5-tropic HIV-1 infection in patients 2 years of age and older weighing at least 10 kg *Expanded the indication from adults to pediatric patients 2 years of age and older weighing at least 10 kg. *Safety, pharmacokinetic profile, and antiviral activity were evaluated in treatment-experienced, CCR5-tropic, HIV-1-infected pediatric patients 2 to less than 18 years weighing at least 10 kg in an open-label, multicenter clinical trial. *The pharmacokinetics, safety, and efficacy in patients younger than 2 years have not been established. *Selzentry is contraindicated in pediatric patients with severe renal impairment or End Stage Renal Disease on regular hemodialysis who are receiving potent CYP3A inhibitors. *There are insufficient data to make dosing recommendations for use in pediatric patients concomitantly receiving noninteracting medications and weighing less than 30 kg or in pediatric patients concomitantly receiving potent CYP3A inducers without a potent CYP3A inhibitor. *The most common adverse reactions in treatment-experienced pediatric patients are vomiting, abdominal pain, diarrhea, nausea, and dizziness. *Information on recommended dosing, Pk parameters and clinical trial. *New oral solution and two lower dose strength tablets. *Postmarketing study Antiviral
10/18/2016 Zemplar paricalcitol Secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3, 4 and 5 in pediatric patients 10 to 16 years *Safety and effectiveness have been established in pediatric patients 10 to 16 years of age. *Use in this age group is supported by evidence from adequate and well controlled studies in adults with CKD, a 12-week double-blind placebo-controlled randomized multicenter study in 36 pediatric patients 10 to 16 years of age with CKD Stages 3 and 4, and safety data from a 12-week open-label single-arm multicenter study in 13 pediatric patients 10 to 16 years of age with CKD Stage 5 receiving peritoneal dialysis or hemodialysis. *Safety and effectiveness in pediatric patients under the age of 10 years have not been established. *Adverse reactions were similar to those reported in adults. *Information on dosing, pharmacokinetic parameters, and clinical trial. *Postmarketing study
10/14/2016 Varibar Pudding barium sulfate Evaluate the oral and pharyngeal function and morphology in adults and pediatric patients 6 months of age and older * Efficacy in pediatric patients above 6 months of age is based on successful opacification of the pharynx during modified barium swallow examinations. * Safety and dosing recommendations in pediatric patients above 6 months of age are based on clinical experience. * Varibar Pudding is contraindicated in pediatric patients with tracheo-esophageal fistula. * Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use. *Information on dosing. * New drug
10/07/2016 Gardasil 9 Human Papillomavirus 9-valent Vaccine, Recombinant* To include a 2-dose regimen for individuals 9 through 14 years of age. See Package Insert for new information on biologics Preventive Vaccine
10/06/2016 Pertzye pancrelipase Postmarketing study * Labeling updated to include new dosage strength of 4,000 USP lipase units. * Infants may be given 4,000 lipase units (one capsule) per 120 mL of formula or breastfeeding. Do not mix Pertzye capsule contents directly into formula or breast milk prior to administration. * New dosage form Pancreatic enzyme
09/27/2016 Avelox moxifloxacin hydrochloride Complicated intra-abdominal infections (cIAI) *Safety and efficacy in pediatric patients for tbe treatment of clAl has not been demonstrated. *Pediatric patients 3 months to <18 years of age (N=451) were enrolled in a single randomized, double blind, active controlled trial in clAl including appendicitis with perforation, abscesses and peritonitis. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, clinical trial. Antibiotic
09/13/2016 CUVITRU Immune Globulin Subcutaneous (Human), 20% Liquid* Indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older See Package Insert for new information on biologics

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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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