• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

  • Print
  • Share
  • E-mail
-

N = 814
n = 744 with New Pediatric Studies; n = 70 with No New Pediatric Studies
BPCA only = 190; BPCA + PREA = 127; PREA only = 448; Rule = 49

Pediatric Labeling Changes as of August 31, 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 .



Advanced Search

   No. of Records Found:  814
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
08/29/2019 Riomet ER metformin hydrochloride Type 2 diabetes mellitus in pediatric patients 10 years and older *Safety and effectiveness as an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years and older with type 2 diabetes mellitus have been established. *Use of for this indication is supported by evidence from adequate and well-controlled studies of metformin HCl immediate-release tablet in adults with additional data from a controlled clinical study using metformin HCl immediate-release tablets in 73 pediatric patients 10 to 16 years old with type 2 diabetes mellitus. *Safety and effectiveness of have not been established in pediatric patients less than 10 years old. *New dosage form. Antidiabetic
08/28/2019 Harvoni Oral Pellets ledipasvir and sofosbuvir Treatment of chronic hepatitis C virus *Expanded indication to pediatric patients 3 to 11 years; previously approved in pediatric patients 12 years and older. *Safety and efficacy have not been established in pediatric patients less than 3 years of age. *Adverse reactions were similar to those observed in adults. *Information on dosing, preparation and administration of oral pellets, PK parameters, adverse reactions, clinical trial. *New dosage form. Antiviral
08/28/2019 Harvoni ledipasvir and sofosbuvir Treatment of pediatric patients 3 to less than 12 years, weighing at least 17 kg, with chronic hepatitis C virus (HCV) *Expanded indication to pediatric patients 3 to 11 years; previously approved in pediatric patients 12 years and older. *Safety and efficacy have not been established in pediatric patients less than 3 years of age. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK parameters, adverse reactions, clinical trial. *New dosage form. Antiviral
08/28/2019 Sovaldi sofosbuvir Treatment of chronic hepatitis C virus * Expanded indication to pediatric patients 3 to 11 years ; previously approved in pediatric patients 12 years and older. *Safety and efficacy have not been established in pediatric patients less than 3 years of age. *Adverse reactions were similar to those observed in adults. *Information on dosing, preparation and administration of oral pellets, PK parameters, adverse reactions, clinical trial. *Two new dosage forms: oral pellets and 200 mg tablet Antiviral
08/22/2019 Tybost cobicistat HIV-1 infection in pediatric patients weighing = 35 kg *Safety and effectiveness co -administered with atazanavir and two nucleoside reverse transcriptase inhibitors for the treatment of HIV-1 infection have been established in virologically suppressed pediatric patients weighing at least 35 kg. *Use for this indication is supported by evidence from adequate and well-controlled studies in adults, and by pharmacokinetic, safety, and virologic data from an open-label trial in virologically suppressed, HIV-1 infected pediatric patients 12 years and older. *Safety through 48 weeks was similar to that in antiretroviral treatment-naïve adults. *Safety and effectiveness in combination with atazanavir in pediatric patients weighing less than 35 kg have not been established. *Safety and effectiveness in combination with darunavir in pediatric patients have not been established. *Information on dosing, PK parameters, adverse reactions, and clinical trial. *Postmarketing study. Antiviral
08/15/2019 Rozlytrek entrectinib Treatment of adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion with a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity Antineoplastic
08/12/2019 Dulera Inhalation Aerosol formoterol fumarate/mometasone furoate Asthma in pediatric patients 5 -11 years *Expanded indication to pediatric patients 5 to 11 years; previously approved in pediatric patients 12 years and older. *Safety and effectiveness have not been established in children younger than 5 years. *Safety profile for pediatric patients is similar to that observed in patients aged 12 years and older. *New Dulera 50 mcg/5 mcg metered dose inhaler. *Information on dosing, PK parameters, adverse reactions, lab abnormalities, and clinical trial. *Postmarketing study. Antiasthmatic
08/12/2019 Asmanex HFA mometasone furoate Asthma in pediatric patients 5 -11 years *Expanded indication to pediatric patients 5 to 11 years; previously approved in pediatric patients 12 years and older. *Safety and effectiveness have not been established in children younger than 5 years. *Safety profile for pediatric patients is similar to that observed in patients aged 12 years and older. *New Asmanex HFA 50 mcg/5 mcg metered dose inhaler. *Information on dosing, adverse reactions, clinical trial. *Postmarketing study. Antiasthmatic
08/08/2019 Clindagel sodium picosulfate, magnesium oxide, and anhydrous citric acid Cleansing of the colon as a preparation for colonoscopy to pediatric patients 9 years and older *Safety and effectiveness have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 9 years and older. *Use in this age group is supported by evidence from adequate and well-controlled trials in adults and a single, dose-ranging, controlled trial in 78 pediatric patients 9 to 16 years of age all of which evaluated another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid. *The safety profile in this pediatric population was similar to that seen in adults. *Monitor for possible hypoglycemia in pediatric patients, as Clenpiq has no caloric substrate. *Safety and effectiveness in pediatric patients less than 9 years have not been established. *Information on dosing, adverse reactions, PK parameters, and clinical trial. *Postmarketing study.
07/30/2019 Enstilar Foam calcipotriene and betamethasone dipropionate Topical treatment of plaque psoriasis in patients 12 years and older *Safety and effectiveness for the treatment of plaque psoriasis of the scalp and body have been established in pediatric patients age 12 to 17 years. *Use for this indication is supported by evidence from adequate and well-controlled trials in adults and from three uncontrolled trials in 216 adolescents. *After 4 weeks of once daily treatment, HPA axis suppression was observed in 3% of adolescents with psoriasis of the scalp and 16% of adolescents with psoriasis of the scalp and body. *Safety and effectiveness in pediatric patients less than 12 years have not been established. *Information on safety, adverse reactions, and pharmacodynamics. *Postmarketing study. Anti-inflammatory, topical
07/25/2019 Taclonex Topical Suspension calcipotriene and betamethasone dipropionate Plaque psoriasis of the scalp and body in patients 12 years and older *Safety and effectiveness for the treatment of plaque psoriasis of the scalp and body have been established in pediatric patients age 12 to 17 years. *Use for this indication is supported by evidence from adequate and well-controlled trials in adults and from three uncontrolled trials in 216 adolescents. *After 4 weeks of once daily treatment, HPA axis suppression was observed in 3% of adolescents with psoriasis of the scalp and 16% of adolescents with psoriasis of the scalp and body. *Safety and effectiveness in pediatric patients less than 12 years have not been established. *Information on safety, adverse reactions, and pharmacodynamics. *Postmarketing study. Anti-inflammatory, topical
07/24/2019 Baqsimi nasal powder glucagon Treatment of severe hypoglycemia in patients with diabetes ages 4 years and older *Safety and effectiveness for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients ages 4 years and above. Use for this indication is supported by evidence from a study in 48 pediatric patients from 4 to <17 years of age with type 1 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients younger than 4 years. *Information on dosing and administration, adverse reactions, clinical trials, and pharmacokinetics and pharmacodynamics. *New dosage form. Antihypoglycemic
07/08/2019 Katerzia oral suspension amlodipine benzoate Hypertension in children 6 years and older *New oral suspension 1 mg/mL approved in pediatric patients 6 years and older. *New dosage form. Antihypertensive
06/20/2019 Botox onabotulinumtoxinA Treatment of upper limb spasticity in pediatric patients 2 to 17 years of age *Safety and effectiveness for the treatment of upper limb spasticity have been established in pediatric patients 2 to 17 years of age, in a clinical study of 234 patients. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study. Antispasmodic
06/18/2019 Biktarvy bictegravir, emtricitabine, and tenofovir alafenamide HIV-1 infected pediatric patients weighing at least 25 kg *Safety and effectiveness were established in pediatric patients with body weight greater than or equal to 25 kg. *Use in pediatric patients between the ages of 6 to less than 18 years and weighing at least 25 kg is supported by trials in adults and by an open-label trial of 100 pediatric patients. *Safety and effectiveness in pediatric patients weighing less than 25 kg have not been established. *There was no clinically significant change in exposure for the components of Biktarvy. *Adverse reactions in pediatric patients were similar to those observed in adults. *Information on dosing, adverse reactions, clinical trials, and PK parameters. *Postmarketing study. Antiviral
06/17/2019 Victoza liraglutide Treatment of type 2 diabetes mellitus in pediatric patients ages 10 years and older *Safety and effectiveness as an adjunct to diet and exercise to improve glycemic control in type 2 diabetes mellitus have been established in pediatric patients 10 years of age and older. *Use for this indication is supported by a 26-week placebo-controlled clinical trial and a 26-week open-label extension in 134 pediatric patients 10 to 17 years with type 2 diabetes, a pediatric pharmacokinetic study, and studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 10 years of age. *The risk of hypoglycemia was higher with Victoza in pediatric patients regardless of concomitant antidiabetic therapies. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *Postmarketing study. Antidiabetic
06/14/2019 Aptensio XR methylphenidate hydrochloride Attention Deficit Hyperactivity Disorder (ADHD) *Safety and effectiveness in pediatric patients under 6 years have not been established. *Safety and efficacy were evaluated in a multicenter, placebo-controlled, double-blind, parallel group study in 119 children 4 to <6 years with ADHD followed by a 12-month open-label extension in 44 of these children. *In these studies, patients experienced high rates of adverse reactions, most notably weight loss. Comparing weights prior to initiation of Aptensio XR (in the safety and efficacy study) to weights after 12 months of treatment (in the open-label extension), 20 of 39 patients with data (50%) had lost enough weight to decrease 10 or more percentiles on a Centers for Disease Control growth chart for weight. In addition, systemic drug exposures in patients 4 to <6 years of age were higher than those observed in older children and adolescents at the same dose (2 to 3 fold higher Cmax and AUC). *Therefore, the benefits do not outweigh the risks in pediatric patients 4 to <6 years. *Postmarketing study. CNS Stimulant
06/06/2019 Nucala mepolizumab Add-on maintenance treatment of patients with severe asthma aged 12 years and older *New liquid formulation approved for subcutaneous injection via Autoinjector (AI) or Safety Syringe Device (SSD). *This formulation is approved for the same dosages, route of administration (SC), and indications for the new SSD and AI presentations as the approved lyophilized drug product. *New dosage form. Antiasthmatic
05/23/2019 Lyrica pregabalin Treatment of partial-onset seizures (POS), to include pediatric patients 1 month to less than 4 years *Safety and effectiveness as adjunctive treatment for POS in pediatric patients 1 month to less than 4 years have been established in a 14-day double-blind, placebo-controlled study (N=175). Previously approved in 4 years and older. *The youngest subject evaluated was 3 months of age; use in patients 1 month to less than 3 months of age is supported by additional pharmacokinetic analyses. *Safety and effectiveness in pediatric patients below the age of 1 month have not been established. *The most common dose-related adverse reactions (>5%) with Lyrica in this study were somnolence, pneumonia, and viral infection. *Information on dosing, adverse reactions, PK parameters, and clinical trial. *Postmarketing study. Anticonvulsant
05/23/2019 Slynd drospirenone Prevention of pregnancy *Safety and efficacy have been established in females of reproductive age. Safety and efficacy are expected to be the same for post-pubertal adolescents under the age of 16 and users 16 years and older. *Study CF111/304 evaluated the bleeding associated with Slynd in females =12 years of age. Bleeding data were generally consistent with those from Study CF111/303 in adult females. *Use of this product before menarche is not indicated. *New dosage form. Contraceptive
05/16/2019 Fragmin dalteparin sodium Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month and older *Safety and effectiveness for the treatment of symptomatic VTE have been established in pediatric patients aged 1 month and older. *Use is supported by evidence from well-controlled studies in adults with additional pharmacokinetic, pharmacodynamic, efficacy, and safety data from two separate studies in pediatric patients aged 1 month and older with symptomatic VTE. *The frequency, type and severity of adverse reactions observed were generally consistent with those observed in adults. *Use preservative-free FRAGMIN in neonates and infants. *Serious adverse reactions including fatal reactions and the "gasping syndrome' occurred in premature neonates and low-birth weight infants in the neonatal intensive care unit who received benzyl alcohol preserved medications. *Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. *When prescribing Fragmin multiple-dose vials in infants consider the combined daily metabolic load of benzyl alcohol from all sources including FRAGMIN multiple-dose vials and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. *Information on dosing, adverse reaction, PK parameters, and clinical trials. Anticoagulant
05/16/2019 Livalo pitavastatin Heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B in pediatric patients 8 years and older *Safety and effectiveness of LIVALO as an adjunctive therapy to diet to reduce elevated TC, LDL-C, and Apo B in pediatric patients aged 8 years and older with HeFH have been established. *Use of LIVALO for this indication is supported by a 12-week, double-blind, placebo-controlled trial in 82 pediatric patients 8 to 16 years of age with HeFH and a 52-week open-label trial in 85 pediatric patients with HeFH. *Safety and effectiveness have not been established in pediatric patients younger than 8 years with HeFH or in pediatric patients with other types of hyperlipidemia (other than HeFH). *Adverse reactions in pediatric patients were similar to those observed in adults. *Information on dosing, adverse reactions, clinical trial Antilipemic
05/15/2019 Gattex teduglutide Short Bowel Syndrome (SBS) in pediatric patients 1 year of age and older *Safety and effectiveness of Gattex have been established in pediatric patients 1 year to less than 17 years of age who are dependent on parenteral support for the treatment of SBS. *Use of Gattex in this population is supported by evidence from adequate and well-controlled studies in adults, with additional efficacy, safety, pharmacokinetic and pharmacodynamic data in pediatric patients 1 year to less than 17 years of age. There were 41 pediatric patients treated with Gattex: 1 infant (1 year to less than 2 years), 37 children (2 years to less than 12 years) and 3 adolescents (12 years to less than 17 years). *Safety and effectiveness in pediatric patients less than 1 year of age have not been established. *Adverse reactions in pediatric patients were similar to those seen in adults. *Information on dosing, adverse reactions, PK parameters and clinical trials. Glucagon-like peptide-2 (GLP-2) analog
05/07/2019 Sutent sunitinib malate Refractory solid tumors *Safety and effectiveness in pediatric patients have not been established. *Safety and pharmacokinetics were assessed in an open-label study in pediatric patients 2 years to <17 years of age (n=29) with refractory solid tumors. In addition, efficacy, safety and pharmacokinetics was assessed in another open-label study in pediatric patients 2 years to <17 years (n=27) with high-grade glioma or ependymoma. *The maximum tolerated dose normalized for body surface area was lower in pediatric patients compared to adults. *Sunitinib was poorly tolerated in pediatric patients. *The effect on open tibial growth plates in pediatric patients who received Sutent has not been adequately studied. *Information on adverse reactions and clinical trials. Antineoplastic
05/06/2019 Sorilux calcipotriene Topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older *Safety and effectiveness have been established in pediatric patients age 12 years and older for topical treatment of plaque psoriasis of the scalp and body. *Use of in this age group is supported by two adequate and well controlled 8-week trials in adults and adolescents 12 years and older, with additional data from an open-label safety and pharmacokinetics study. *The safety and effectiveness of in pediatric patients less than 12 years of age have not been established. *Information on adverse reactions, PK parameters, and clinical trials. Antipsoriatic, topical
05/01/2019 DENGVAXIA DENGUE Tetravalent Vaccine, Live* Indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas. See Package Insert for new information on biologics Preventive Vaccine
04/30/2019 Mavyret glecaprevir and pibrentasvir Chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) *Expanded the indication to adolescents 12 years and older or weighing at least 45 kilograms (kg); previously approved in adults. *Safety, efficacy, and pharmacokinetics in HCV GT1, 2, 3, or 4 infected pediatric patients 12 years and older or weighing at least 45 kg is based on data from an open-label trial in 47 subjects without cirrhosis aged 12-18 years who were either treatment naïve (n=36) or treatment experienced (n=11) and received Mavyret for 8 or 16 weeks. *The safety and efficacy results observed in this trial were consistent with those observed in clinical studies of Mavyret in adults. *In pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or HCV GT5 or 6 infection, the safety and efficacy of Mavyret are supported by the comparable glecaprevir and pibrentasvir exposures observed between adolescents and adults. *Safety and effectiveness in children less than 12 years of age have not been studied. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *Postmarketing study. Antiviral
04/26/2019 Benlysta belimumab Treatment of patients with active, antibody systemic lupus erythematosus (SLE) to include children aged 5 to 17 years *Expanded indication to pediatric patients 5 to 17 years. *Determination of efficacy in pediatric patients was based on pharmacokinetic (PK) and efficacy results from a pediatric SLE study, as well as PK exposure and extrapolation of the established efficacy of Benylsta plus standard therapy from the Phase 3 intravenous studies in adults. A randomized, double-blind, placebo-controlled, PK, efficacy, and safety study to evaluate intravenously administered Benlysta 10 mg/kg plus standard therapy compared with placebo plus standard therapy over 52 weeks was conducted in 93 pediatric patients with SLE. The proportion of pediatric patients achieving an SRI-4 response was higher in patients receiving Benlysta plus standard therapy compared with placebo plus standard therapy. *Pediatric patients receiving Benlysta plus standard therapy also had a lower risk of experiencing a severe flare compared with the placebo group. *The adverse event profile in pediatric patients was consistent with the overall population in the Phase 3 studies in adults. *Safety and effectiveness of have not been established in pediatric patients younger than 5 years of age. *Safety and effectiveness of subcutaneous administration of Benlysta have not been established in pediatric patients younger than 18 years of age. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *Postmarketing study. Immunosuppressant
04/22/2019 Corlanor Oral Solution ivabradine Treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate *Safety and effectiveness have been established in pediatric patients age 6 months to less than 18 years old and are supported by pharmacokinetic and pharmacodynamic trials and evidence from adequate and well-controlled trials of Corlanor in adult patients. *The pediatric study included 116 patients in the following age groups: 17 patients in the 6 months to less than 12 months age group, 36 patients in the 1 year to less than 3 years age group, and 63 patients in the 3 years to less than 18 years age group. *Safety and efficacy have not been established in patients less than 6 months of age. *Bradycardia and first-degree heart block were observed in pediatric patients treated with Corlanor. *Asymptomatic and symptomatic bradycardia were observed in 6.8% and 4.1% of pediatric patients treated with Corlanor, respectively. *Phosphenes were observed in pediatric patients treated with Corlanor. *Information on dosing, adverse reactions, PK parameters and clinical trial. *New dosage form. Heart failure
04/18/2019 Opdivo nivolumab Treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) *New recommended dosage regimens for nivolumab for the treatment of patients with MSI-H or dMMR mCRC in adults and pediatric patients. *Additionally, a modification of the recommended dosage regimen for nivolumab in adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC for OPDIVO 240 mg intravenously over 30 minutes every 2 weeks until disease progression or unacceptable toxicity, to limit this dosage regimen to adult and pediatric patients weighing 40 kg or more. *Postmarketing study. Antineoplastic
04/03/2019 Welchol Chewable Bar colesevelam HCl Reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy *New Chewable Bars: 3.75 gram per bar. *Information on dosing and administration. *New dosage form. Antilipemic
03/29/2019 Octaplas Pooled Plasma (Human), Solvent/Detergent Treated* Indicated (1) as replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery and liver transplantation and (2) plasma exchange in patients with thrombotic thrombocytopenic purpura See Package Insert for new information on biologics Pooled human plasma
03/21/2019 Doptelet avatrombopag Juvenile animal toxicity study •Safety and effectiveness in pediatric patients have not been established. • In a 10-week juvenile toxicology study in rats, avatrombopag was administered at doses ranging from 20 to 300 mg/kg/day. There were no test article-related mortality or clinical signs at doses up to 300 mg/kg/day. In the stomach, dose-dependent degeneration, regenerative hyperplasia, and atrophy of the glandular epithelium occurred at 100 and 300 mg/kg/day; exposures at 100 mg/kg/day in male rats were 14-times the AUC in patients at the recommended dose of 60 mg once daily. An increased incidence of background focal mineralization was also observed in the kidneys of females at 300 mg/kg/day (female rat exposure was 50-times the human exposure based on AUC at the 60 mg daily dose). •Postmarketing study
03/14/2019 Avycaz ceftazidime/ avibactam Treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) to include patients 3 months to less than 18 years *Safety and effectiveness in the treatment of cUTI and cIAI have been established in pediatric patients 3 months to less than 18 years. Use in these age groups is supported by evidence from adequate and well-controlled studies of Avycaz in adults with cUTI and cIAI and additional pharmacokinetic and safety data from pediatric trials. *Safety and effectiveness in pediatric patients below the age of 3 months with cUTI or cIAI have not been established. *Safety and effectiveness in pediatric patients less than 18 years of age with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia have not been established. *Dosage adjustment is required in pediatric patients with cIAI or cUTI and renal impairment from 2 years to < 18 years with eGFR 50 mL/min/1.73 m2 or less. There is insufficient information to recommend a dosing regimen for pediatric patients younger than 2 years of age with cIAI or cUTI and renal impairment. * Safety in patients ages 3 months to less than 18 years was similar to that observed in adults. *Information on recommended dosing, dosing in renal impairment patients, PK parameters and clinical trials in patients ages 3 months to less than 18 years. *Postmarketing study. Antibiotic
03/11/2019 Dupixent dupilumab Moderate-to-severe atopic dermatitis *Safety and efficacy have been established in pediatric patients 12 years and older. *A total of 251 adolescents ages 12 to 17 years old with moderate-to-severe atopic dermatitis were enrolled in the clinical trial. *Safety and efficacy in pediatric patients less than12 years with atopic dermatitis have not been established. *The safety profile in pediatric patients is similar to that in adults. *Information on adverse reactions, PK parameters and clinical trial. *Postmarketing study. Monoclonal antibody
03/01/2019 Flector Topical System diclofenac epolamine Topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older *Safety and effectiveness have been established in pediatric patients 6 years and older based on evidence from adequate and well-controlled studies in adults, as well as an open-label study in 104 pediatric patients 6 years and older. *The safety profile of Flector topical system in pediatric patients is similar to that in adults. *Safety and effectiveness have not been investigated in pediatric patients less than 6 years old. *Information on adverse reactions, PK parameters and clinical trial. *Postmarketing study. Anti-inflammatory, topical
02/27/2019 Adhansia XR methylphenidate hydrochloride Attention Deficit Hyperactivity Disorder *Safety and effectiveness have been established in one adequate and well-controlled 6-week study in pediatric patients ages 6 to 12 years, and in one adequate and well-controlled 4-week study in pediatric patients ages 12 to 17 years. *Safety and effectiveness in pediatric patients under the age of 6 years have not been established. *The long-term efficacy of methylphenidate in pediatric patients has not been established. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *New dosage form. CNS Stimulant
02/22/2019 Chantix varenicline Aid to smoking cessation treatment *Chantix is not recommended for use in pediatric patients 16 years or younger because its efficacy in this population was not demonstrated. *Efficacy and safety of varenicline were evaluated in a randomized, double-blind, placebo-controlled study of 312 patients aged 12 to 19 years. Results from this study showed that varenicline, at either dose studied, did not improve continuous abstinence rates at weeks 9 through 12 of treatment compared with placebo in patients 12 to 19 years. *Varenicline safety profile in this study was consistent with that observed in adult studies. *Information on pharmacokinetics. Smoking cessation
02/19/2019 ESPEROCT Antihemophilic Factor (Recombinant), GlycoPEGylated-exei* For use in adults and children with hemophilia A for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes See Package Insert for new information on biologics Antihemophilic Factor
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 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
12/21/2018 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
12/12/2018 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
11/07/2018 Primatene Mist epinephrine Temporary relief of mild symptoms of intermittent asthma in adults and children 12 years and older *Approved for use in adults and pediatric patients 12 years and older. *Not approved in pediatric patients less than 12 years. Antiasthmatic
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

Prev  |  Next  |  [1]  |  2  |  3  |  4  |  5  |  First  |  Last  |  All

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:
[INVALID]

Biological labeling and reviews:
[INVALID]

BPCA 2002 Review Summaries:
[INVALID]

**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.

-
-