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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 854
n = 792 with New Pediatric Studies; n = 62 with No New Pediatric Studies
BPCA only = 199; BPCA + PREA = 131; PREA only = 475; Rule = 49

Pediatric Labeling Changes as of April 2020

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:  854
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
04/20/2020 Cymbalta duloxetine Fibromyalgia in pediatric patients 13 to 17 years Label Change Summary - Use for treatment of fibromyalgia in patients 13 to 17 years of age is supported by a 13-week placebo-controlled trial in 184 patients with juvenile fibromyalgia syndrome. - Cymbalta showed improvement over placebo on the primary endpoint, change from baseline to end-of-treatment on the Brief Pain Inventory (BPI) – Modified Short Form: Adolescent Version 24-hour average pain severity rating. - Safety and effectiveness for the treatment of fibromyalgia in patients less than 13 years of age have not been established. - Information on dosing, adverse reactions, and clinical trial. - Postmarketing study. Antidepressant
03/26/2020 Taltz ixekizumab Moderate-to-severe plaque psoriasis *Safety and effectiveness have been established in pediatric patients 6 years to less than 18 years with moderate-to-severe plaque psoriasis. *Safety and effectiveness in other pediatric indications and for pediatric patients less than 6 years of age have not been established. *In the clinical trial, Crohn's disease occurred at a greater frequency in the treatment group (0.9%) than the placebo group (0%) during the 12-week, placebo-controlled period. Crohn's disease occurred in a total of 4 Talkz treated patients (2.0%) in the clinical trial. *Safety profile was similar to those observed in adults with plaque psoriasis with the exception of the frequencies of conjunctivitis (2.6%), influenza (1.7%), and urticaria (1.7%). *Information on dosing, adverse reactions, PK parameters and clinical trial. *Postmarketing study. Humanized interleukin-17A antagonist
03/23/2020 Eucrisa ointment crisaborole Mild to moderate atopic dermatitis in patients 3 months to less than 2 years *Safety and effectiveness have been established in pediatric patients 3 months and older for topical treatment of mild to moderate atopic dermatitis. *Use in this age group is supported by data from two 28-day, vehicle-controlled safety and efficacy trials which included 1,313 pediatric patients ages 2 years to 17 years whom received Eucrisa. *Use in pediatric patients ages 3 months to less than 2 years was supported by data from a 28-day open-label, safety and pharmacokinetics (PK) trial in 137 patients. *Safety and effectiveness in pediatric patients below the age of 3 months have not been established. *No new safety signals were identified in patients 3 months to less than 2 years. *Information on adverse reactions, PK parameters, and clinical studies. *Postmarketing study. Phosphodiesterase 4 inhibitor
03/19/2020 Epclusa Sofosbuvir/velpatasvir Treatment of chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection in pediatric patients 6 years of age and older or weighing at least 17 kg *The pharmacokinetics, safety, and effectiveness have been established in an open-label, multicenter clinical trial. *Safety and effectiveness for treatment of HCV genotype 5 in pediatric patients 6 years and older or weighing at least 17 kg without cirrhosis or with compensated cirrhosis are supported by sofosbuvir, GS-331007, and velpatasvir exposures in adults and pediatric patients. *In patients with severe renal impairment, including those requiring dialysis, exposures of GS-331007, the inactive metabolite of sofosbuvir, are increased. *No data are available regarding the safety in pediatric patients with renal impairment. *Safety and effectiveness have not been established in pediatric patients less than 6 years. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *New 200 mg/50 mg strength tablet. Antiviral
03/04/2020 Cleocin Phosphate clindamycin injection; clindamycin injection in dextrose Postmarketing study *The following statement was added to Dosage and Administration section: Clindamycin should be dosed on total body weight regardless of body weight. *Obese Pediatric Patients Aged 2 to Less than 18 Years and Obese Adults Aged 18 to 20 Years: An analysis of pharmacokinetic data in obese pediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years demonstrated that clindamycin clearance and volume of distribution, normalized by total body weight, are comparable regardless of obesity. *Off-patent Written Request. Antibiotic
03/04/2020 Acticlate; Acticlate Cap doxycycline hyclate Postmarketing study *Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 children (2-18 years) showed that allometrically-scaled clearance of doxycycline in children =2 to =8 years did not differ significantly from children >8 to 18 years. *No clinically significant difference in CL differences between oral and IV were observed in the small cohort of pediatric patients who received the oral (N=19) or IV (N=21) formulation alone. *Off-patent written request. Antibiotic
03/02/2020 Cafcit Injection caffeine citrate Postmarketing study *Expanded indication to include a broader gestational age (GA) range of premature infants. The lower and upper GA limits were removed from the Indications and Usage; previously indicated for the short-term use in infants between 28 - <32 weeks gestational age. *The term "short-term" was removed from the Indications and Usage section allowing for a longer treatment duration. *In a published randomized, placebo-controlled, clinical trial that studied the use of caffeine citrate in apnea of prematurity in approximately 2000 patients, necrotizing enterocolitis was not more common in caffeine treated patients compared to placebo. *Information on dosing, adverse reactions, and clinical trial. *Off-patent Written Request. Bronchial smooth muscle relaxant
02/12/2020 Doryx; Doryx MPC doxycycline hyclate Postmarketing study *Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 children (2-18 years of age) showed that allometrically-scaled clearance of doxycycline in children =2 to =8 years did not differ significantly from children >8 to 18 years. *No clinically significant difference in CL differences between oral and IV were observed in the small cohort of pediatric patients who received the oral (N=l9) or IV (N=21) formulation alone. *Off-patent written request. Antibiotic
01/31/2020 AUDENZ Influenza A (H5N1) Monovalent Vaccine, Adjuvanted* Active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine in persons 6 months and older See Package Insert for new information on biologics Preventive Vaccine
01/31/2020 PALFORZIA Peanut (Arachis hypogaea) Allergen Powder-dnfp* Mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years and older See Package Insert for new information on biologics Allergenic extract
01/31/2020 Viibryd vilazodone hydrochloride 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 studies including a total of 1002 pediatric patients ages 7 years to 17 years of age with MDD. *The following adverse reactions were reported in at least 5% of pediatric patients treated with Viibryd and occurred at a rate at least twice that for pediatric patients receiving placebo: nausea, vomiting, diarrhea, abdominal pain/discomfort, and dizziness. *Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients. Antidepressant
01/24/2020 Dificid fidaxomicin Treatment of Clostridioides difficile-associated diarrhea (CDAD) in pediatric patients 6 months to 17 years *Safety and effectiveness of the treatment of CDAD have been established in pediatric patients 6 months to 17 years. *Use of fidaxomicin in these age groups is supported by evidence from adequate and well-controlled trials of fidaxomicin in adults with CDAD and pharmacokinetic, safety and efficacy data from pediatric trials. *Adverse reactions are similar to those observed in adults. *Safety and effectiveness have not been established in pediatric patients younger than 6 months. *Information on dosing, Adverse Reactions, PK parameters and clinical trials. *New oral suspension. *Postmarketing study. *Summary pending.
12/20/2019 Mycamine micafungin Treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age *Safety and effectiveness at a dose of 4 mg/kg once daily have been established in pediatric patients without meningoencephalitis and/or ocular dissemination younger than 4 months. *This use and dose are supported by evidence from adequate and well-controlled studies in adult and pediatric patients 4 months and older with additional pharmacokinetic and safety data in pediatric patients younger than 4 months of age. *Safety and effectiveness have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months as a higher dose may be needed. *Safety and effectiveness in pediatric patients younger than 4 months have not been established for (1) the treatment of esophageal candidiasis and (2) prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. *Information on dosing, adverse reactions, PK parameters and clinical trials. *Postmarketing study. Antiviral
12/20/2019 Vibramycin, Vibra-Tabs doxycycline monohydrate; doxycycline hyclate; doxycycline calcium; doxycycline hyclate Postmarketing study *Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 pediatric patients 2-18 years showed that allometrically -scaled clearance (CL) of doxycycline in pediatric patients =2 to =8 years of age did not differ significantly from pediatric patients >8 to 18 years. *For pediatric patients weighing =45 kg, body weight normalized doxycycline CL in those =2 to =8 years did not differ significantly from those >8 to 18 years. * In pediatric patients weighing >45 kg, no clinically significant differences in body weight normalized doxycycline CL were observed between those =2 to =8 years and those >8 to 18 years of age. *No clinically significant difference in CL between oral and IV dosing was observed in the small cohort of pediatric patients who received the oral (N=19) or IV (N=2l) formulation alone. *Off-patent Written Request. Antibiotic
12/19/2019 Conjupri levamlodipine Hypertension in adults and pediatric patients 6 years and older *Indicated in patients 6 to 17 years. *Effect of levamlodipine on blood pressure in patients less than 6 years of age is not known. *Information on dosing, PK parameters, and clinical trials. *New active ingredient. Antihypertensive
12/19/2019 Fiasp insulin aspart Diabetes mellitus in pediatric patients *Safety and effectiveness have been established to improve glycemic control in pediatric patients with diabetes mellitus. *Use for this indication is supported by evidence from an adequate and well-controlled study in 777 pediatric patients with type 1 diabetes mellitus aged 2 to 17 years, and from studies in adults with diabetes mellitus. *Pediatric patients with type 1 diabetes treated with mealtime and postmeal FIASP reported a higher rate of blood glucose confirmed hypoglycemic episodes compared to patients treated with NovoLog; the imbalance was greater during the nocturnal period. *Monitor blood glucose levels closely in pediatric patients. *Information on dosing, adverse reactions, PK parameters and clinical trials. *Postmarketing study. Antidiabetic
12/18/2019 Aralzo tazarotene Acne *Safety and effectiveness for the topical treatment of acne vulgaris have been established in pediatric patients age 9 years and older based on evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled, 12-week clinical trials and an open-label pharmacokinetic study. *A total of 300 pediatric subjects aged 9 to less than 17 years received Arazlo in the clinical studies. *Safety and effectiveness in pediatric patients below the age of 9 years have not been established. *New dosage form. Antiacne, topical
12/06/2019 Abraxane paclitaxel Recurrent or refractory pediatric solid tumors *Safety and effectiveness in pediatric patients have not been established. *Pharmacokinetics, safety, and antitumor activity were assessed in an open-label, dose escalation, dose expansion study in 96 pediatric patients aged 1.4 to < 17 years with recurrent or refractory pediatric solid tumors. *The maximum tolerated dose (MTD) normalized for body surface area (BSA) was lower in pediatric patients compared to adults. *No new safety signals were observed in pediatric patients across these studies. *Paclitaxel protein-bound exposures normalized by dose were higher in 96 pediatric patients aged 1.4 to < 17 years as compared to those in adults. Antineoplastic
12/04/2019 Latuda lurasidone hydrochloride Postmarketing study *In a long-term, open-label study that enrolled pediatric patients age 6 to 17 years with schizophrenia, bipolar depression, or autistic disorder from three short-term, placebo-controlled trials, 54% (378/701) received lurasidone for 104 weeks. *In this trial, the mean increase in height from open-label baseline to Week 104 was 4.94 cm. The mean change in height z-score indicates a minimal deviation from the normal growth curve. *Postmarketing study. Antipsychotic
11/15/2019 Harvoni ledipasvir and sofosbuvir Treatment of chronic hepatitis C virus infection in patients with severe renal impairment including patients with end stage renal disease on dialysis *In patients with severe renal impairment, including those requiring dialysis, exposures of the inactive metabolite of sofosbuvir are increased. *• No data are available regarding the safety of Harvoni in pediatric patients with renal impairment. *Postmarketing study. Antiviral
11/13/2019 Lumason Sulfur Hexafluoride Lipid-Type A Microspheres Use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms *Safety and effectiveness have been established for use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left endocardial border. *Safety and effectiveness in pediatric patients are based on adequate and well-controlled studies in adults and are supported by a clinical study in 12 pediatric patients with extrapolation of efficacy to younger pediatric patients. *No new adverse reactions were reported in the pediatric study. *Safety of intravenous use of Lumason was based on evaluation of published literature involving the use of Lumason in over 1400 pediatric patients (0 to 17 years). *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study. Medical imaging
11/05/2019 Sorilux calcipotriene Topical treatment of plaque psoriasis of the scalp and body in pediatric patients 4 years and older *Expanded the indication down to patients 4 years of age and older; previously approved for use in 12 years and older. *Safety and effectiveness in pediatric patients less than 4 years have not been established. *Information on PK, and clinical trial. *Postmarketing study. Vitamin D analog
10/25/2019 Opana oxymorphone HCl Postoperative pain *Safety and effectiveness for pediatric patients, 0 to 17 years, have not been established. *An open-label study was conducted in 58 pediatric patients 12 years and older with postoperative pain. Efficacy was not demonstrated in this population treated with doses expected to be comparable to effective starting doses in adults. *Pharmacokinetic results demonstrated that treatment with Opana tablets resulted in substantially higher systemic exposures to oxymorphone in 2 out of 24 patients. *Not recommended for use in the pediatric population. *Postmarketing study. Analgesic
10/18/2019 Amzeeq minocycline 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 pediatric patients 9 years and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris. *Use for this indication is supported by three adequate and well-controlled 12-week trials in patients 9 years and older. A total of 686 patients 9 years and older received Amzeeq in these clinical trials. *Safety and effectiveness for this indication have not been established in pediatric patients less than 9 years. *The use of oral tetracycline drugs during tooth development below the age of 8 years may cause permanent discoloration of the teeth and inhibition of bone growth. *Information on PK parameters and clinical trials. *New dosage form. Antiacne, topical
10/18/2019 Ultomiris ravulizumab-cwvz Treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). *Safety and effectiveness for the treatment of aHUS have been established in pediatric patients aged one month and older. *Use for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic, safety, and efficacy data in pediatric patients aged 10 months to <17 years. *Safety and efficacy for the treatment of paroxysmal nocturnal hemoglobinuria in pediatric patients have not been established. *Information on dosing recommendations and considerations, adverse reactions, and clinical trial. *New indication. Humanized monoclonal antibody
10/18/2019 Botox onabotulinumtoxinA Treatment of lower limb spasticity in pediatric patients 2 to 17 years of age *Safety and effectiveness have been established in pediatric patients 2 to 17 years. *Safety and effectiveness of have been established by evidence from adequate and well-controlled studies of Botox in patients 2 to 17 years with lower limb spasticity. However, treatment Botox for this indication is not intended to substitute for usual standard of care rehabilitation regimens. *A pediatric assessment for Botox demonstrated that it is safe and effective in another pediatric population. However, Botox is not approved for such patient population due to marketing exclusivity for another botulinum toxin. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. *Information on dosing, adverse reactions, and clinical trials. *Postmarketing study. Neuromuscular blocking agent
10/10/2019 Wilate von Willebrand Factor/Coagulation Factor VIII Complex (Human)* Indicated in pediatric subjects and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on-demand treatment and control of bleeding episodes See Package Insert for new information on biologics Antihemophilic Factor
10/04/2019 Quzyttir cetirizine hydrochloride Treatment of acute urticaria in adults and children 6 months of age and older *Safety and efficacy have been established in patients 6 months to 17 years of age. *Efficacy for the treatment of acute urticaria down to 6 months is based on extrapolation of the efficacy of Quzyttir in adults with acute urticaria and supported by pharmacokinetic data with oral cetirizine hydrochloride in patients 6 months to 17 years of age. *Based upon the known PK profile of oral cetirizine hydrochloride, the exposure of IV cetirizine hydrochloride in pediatric patients 6 months to 17 years is expected to be similar to the exposure of IV cetirizine hydrochloride in adults at the labeled doses. *Safety in children 6 months to 17 years of age is supported by safety information from placebo-controlled clinical trials with oral cetirizine hydrochloride in patients 6 months of age and older. *Quzyttir demonstrates a higher Cmax compared to oral cetirizine hydrochloride in adults. *Because of the absence of pharmacokinetic and safety information for cetirizine hydrochloride in children below 6 years with impaired renal or hepatic function, use in this impaired patient population is not recommended. *Safety and efficacy in patients less than 6 months of age has not been established. *Information on PK parameters and clinical trials. *New dosage form. Antihistamine, topical
10/04/2019 Aklief trifarotene Acne vulgaris *Safety and effectiveness for the topical treatment of acne vulgaris have been established in pediatric patients age 9 years to 17 years based on evidence from well-controlled clinical trials, a long-term safety trial, and a pharmacokinetic trial. A total of 897 pediatric subjects aged 9 to 17 years received Aklief Cream in the clinical trials. *Safety and effectiveness have not been established in pediatric subjects under the age of 9 years. *Information on PK parameters and clinical trials. Antiacne, topical
10/03/2019 Tybost cobicistat Co-administered with darunavir for treatment of HIV-1 infection in 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 aged 12 years and older. *The safety in these patients through 48 weeks was similar to that in antiretroviral treatment-naïve adults. *Safety and effectiveness in combination with darunavir in pediatric patients weighing less than 40 kg have not been established. • Adverse reactions were similar to those observed in adults. *Information on dosing, PK parameters, clinical trial. *Postmarketing study. Antiviral
10/03/2019 Descovy emtricitabine and tenofovir alafenamide Pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection *Safety and effectiveness for HIV-1 PrEP in at-risk adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex, is supported by data from an adequate and well-controlled trial for HIV-1 PrEP in adults with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, FTC and TAF, with EVG+COBI, in HIV-1 infected adults and pediatric subjects. *While using DESCOVY for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs. Previous studies in at-risk adolescents indicated waning adherence to a daily oral PrEP regimen once visits were switched from monthly to quarterly visits. Adolescents may therefore benefit from more frequent visits and counseling. *Safety and effectiveness for HIV-1 PrEP in pediatric patients less than 35 kg have not been established. *Information on dosing, adverse reactions, PK parameters, and clinical trial. Antiviral
10/01/2019 Entresto sacubitril/valsartan Treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older *Safety and effectiveness in pediatric heart failure patients 1 to <18 years old are supported by the reduction from baseline to 12 weeks in NT-proBNP in a randomized, double-blind clinical study [see Clinical Studies (14.2)]. The analysis of NT-proBNP included 90 patients age 6 to 18 years and 20 patients age 1 to 6 years. *Safety and effectiveness have not been established in pediatric patients less than 1 year of age. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK parameters, clinical trial, and preparation of oral solution. *New indication. Heart failure
09/26/2019 Mavyret glecaprevir and pibrentasvir Chronic hepatitis C virus infection (HCV) 12 years and older or weighing at least 45 kg *The treatment duration for chronic HCV for treatment-naïve patients was changed from 12 weeks to 8 weeks. *The new 8-week treatment duration for genotypes (GTs) 1,2,3,4,5 and 6 for treatment-naïve patients with compensated cirrhosis with Chronic Hepatitis C Virus (HCV) infection is supported by the EXPEDITION-8 study. *Information on dosing, and clinical trial. *New dosing regimen. *Postmarketing study. Antiviral
09/25/2019 Dysport abobotulinumtoxinA Treatment of upper limb spasticity in pediatric patients 2 years and older *Approved for the treatment of upper limb spasticity in pediatric patients 2 years and older, excluding spasticity caused by cerebral palsy. *Safety and effectiveness have been established by evidence from adequate and well-controlled studies in patients 2 years and older with upper limb spasticity. *A pediatric study demonstrated that Dysport is safe and effective in another pediatric population. However, Dysport is not approved for such patient population due to marketing exclusivity for another botulinum toxin. *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
09/13/2019 Teflaro Injection ceftaroline fosamil Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) to include pediatric patients from birth to less than 2 months *Safety and effectiveness in the treatment of ABSSSI have been established in pediatric patients (at least 34 weeks gestational age and 12 days postnatal age); previously approved down to 2 months. *Use of Teflaro in pediatric patients less than 2 months of age was supported by pharmacokinetic and safety data in 11 infants at least 34 weeks gestational age and 12 days postnatal age. *Safety and effectiveness in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age for the treatment of ABSSSI have not been established. *Adverse reactions were similar to those observed in adults. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study. Antibiotic
09/13/2019 Mydayis mixed salts of a single-entity amphetamine Attention Deficit Hyperactivity Disorder (ADHD) *Safety and effectiveness have not been established in pediatric patients ages 12 years and younger. *Mydayis has been studied for the treatment of ADHD in pediatric patients 6 to 12 years in two placebo-controlled safety and efficacy trials. *In the first trial, pediatric patients 6 to 12 years 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 in pediatric patients 6 to 12 years following a single dose were higher than those observed in adults at the same dose (72-79% higher Cmax and approximately 83% higher AUC). A second trial evaluated a lower dose than those approved for pediatric patients 13 to 17 years; efficacy was not demonstrated for the lower dose. *A safe and effective dose cannot be established in pediatric patients 12 years and younger. *Information on adverse reactions, PK parameters, and clinical trials. *Postmarketing requirement. CNS Stimulant
09/12/2019 Nucala mepolizumab Add-on maintenance treatment of patients with severe asthma, and with an eosinophilic phenotype to include patients aged 6 to 11 years *Safety and efficacy for severe asthma, and with an eosinophilic phenotype, have been established in pediatric patients aged 6 years and older; previously approved down to 12 years and older. *Use in children 6 to 11 years with severe asthma, and with an eosinophilic phenotype, is supported by evidence from adequate and well-controlled trials in adults and adolescents with additional pharmacokinetic, pharmacodynamic, and safety data in children aged 6 to 11 years. A single, open-label clinical trial was conducted in 36 children aged 6 to 11 years with severe asthma. *Based upon the pharmacokinetic data from this trial, a dose of 40 mg SC every 4 weeks was determined to have similar exposure to adults and adolescents administered a dose of 100 mg SC. *Efficacy in children aged 6 to 11 years is extrapolated from efficacy in adults and adolescents with support from pharmacokinetic analyses showing similar drug exposure levels for 40 mg administered subcutaneously every 4 weeks in children aged 6 to 11 years compared with adults and adolescents. *The safety profile and pharmacodynamic response observed in this trial for children aged 6 to 11 years were similar to that seen in adults and adolescents. *Safety and efficacy in pediatric patients aged younger than 6 years with severe asthma have not been established. *Information on dosing, and PK parameters. *Postmarketing study. Antiasthmatic
09/10/2019 Aczone Gel dapsone Acne vulgaris *Expanded the patient population to down to 9 years of age and older; previously approved down to 12 years. *Use in patients 9 to 11 years of age for this indication is supported by evidence from adequate and well-controlled clinical trials in 1066 patients 12 years and older and with additional pharmacokinetic and safety data in pediatric patients 9 to 11 years from an open label study of 100 patients with acne. *The adverse reactions in clinical trials was similar to the vehicle control group. *Safety and effectiveness have not been established in pediatric patients below 9 years of age. *Postmarketing study. Antiacne, topical
09/10/2019 Gvoke glucagon Severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above *Safety and effectiveness for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients ages 2 years and above. *Use for this indication is supported by evidence from a study in 31 pediatric patients ages 2 and older with type 1 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients younger than 2 years of age. *New dosage form. *Postmarketing study. Antihypoglycemic
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 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
08/28/2019 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
08/22/2019 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 Clenpiq 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

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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:
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Biological labeling and reviews:
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BPCA 2002 Review Summaries:
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**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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