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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 533
n = 484 with New Pediatric Studies; n = 49 with No New Pediatric Studies
BPCA only = 161; BPCA + PREA = 73; PREA only = 249; Rule = 49; None = 1

Pediatric Labeling Changes as of October 9,2014

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, select the pediatric labeling date in the first column of the database to reveal the additional information. To view all records in the database, select 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 select 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:  533
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
03/15/2013 Recothrom Thrombin, topical (Recombinant) * Aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical See Package Insert for new information on biologics Topical thrombin
02/27/2013 Intelence etravirine Postmarketing study *Information on 48 week safety*The safety profile for patients who completed 48 weeks of treatment was similar to the safety profile for patients who completed 24 weeks of treatment*Postmarketing study Antiviral
02/06/2013 Zylet loteprednol etabonate and tobramycin Treatment of blepharoconjunctivitis "" Efficacy was not demonstrated in a study of pediatric patients 0-6 years" Antibiotic, topical
02/01/2013 Epiduo adapalene and benzoyl peroxide Treatment of acne vulgaris *Expanded age range down to 9 years; previously approved in pediatric patients 12 years and older*Safety and effectiveness in pediatric patients < 9 years have not been established*Adverse reactions were similar to those observed in adults*Information on clinical trial*Postmarketing study Antiacne, topical
02/01/2013 Prezista darunavir Treatment of HIV-1 infection *Revised labeling to include once daily dosing in treatment naïve and treatment experienced HIV-1 infected pediatric patients 3 to < 18 years and weighing at least 10 kg * Postmarketing study Antiviral
01/25/2013 Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) * Active immunization for the prevention of invasive pneumococcal disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F See Package Insert for new information on biologics Preventive Vaccine
01/23/2013 Exjade deferasirox Treatment of chronic iron overload in patients with non-transfusion dependent thalassemia *Approved for use in 10 years and older for NTDT *Safety and effectiveness have not been established in pediatric patients less than 10 years * Information on dosing, adverse reactions in adults and pediatric patients, and clinical trials * New indication Iron chelator
01/09/2013 Skyla levonorgestrel-releasing intrauterine system Prevention of pregnancy for up to 3 years *Safety and efficacy have been established in women of reproductive age*Efficacy is expected to be the same for postpubertal females under the age of 18 years as for users 18 years and older*Use of this product before menarche is not indicated*New drug Contraceptive
12/21/2012 Altabax Ointment retapamulin Treatment of impetigo *Use of retapamulin is not indicated in pediatric patients < 9 months* In an open-label clinical study of topical treatment in pediatric patients 2 to 24 months, systemic exposure of retapamulin was higher compared with patients 2 to 17 years. A higher proportion of pediatric patients 2 to 9 months of age had measurable concentrations of retapamulin compared with patients 9 to 24 months of age. The highest levels were seen in patients 2 to 6 months of age*Postmarketing study Antibiotic, topical
12/19/2012 Advair HFA fluticasone/ salmeterol Treatment of asthma *Safety and effectiveness in children < 12 years have not been established.* Information on clinical trials, adverse reactions, and pharmacokinetics/ pharmacodynamics, * Postmarketing study Antiasthmatic
12/14/2012 Fluarix Quadrivalent Influenza Virus Vaccine* Include a quadrivalent influenza virus vaccine formulation (Fluarix® Quadrivalent) See Package Insert for new information on biologics Vaccine
11/30/2012 Invirase saquinavir Treatment of HIV infection in combination with ritonavir *The safety and activity of saquinavir have been evaluated in 68 pediatric patients 4 months -< 16 years treated with Invirase boosted with either ritonavir or with lopinavir/ritonavir in 2 clinical trials. * Steady state saquinavir exposures observed in pediatric trials were substantially higher than historical data in adults where dose- and exposure-dependent QTc and PR prolongation were observed. Pediatric dose recommendations that are both reliably effective and below thresholds of concern with respect to QT and PR prolongation could not be determined. * Information on clinical studies, and pharmacokinetics Antiviral
11/08/2012 VIRAMUNE XR nevirapine Treatment of HIV-1 infection * Approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in children 6 - < 18 years. Use in pediatric patients 6 - < 18 years is based on pharmacokinetic, safety, and antiviral activity data from an open-label trial and supported by previous demonstration of efficacy in adults. * Not recommended for children < 6 years since clinical trial did not provide sufficient pharmacokinetic data for children 3 - < 6 years to support the use in this age group. Furthermore, not recommended for children < 3 years because they are not able to swallow tablets. * Viramune XR tablets must be swallowed whole and must not be chewed, crushed, or divided. * Children should be assessed for their ability to swallow tablets before prescribing * No recommendations can be made regarding substitution of four VIRAMUNE XR 100 mg tablets for one VIRAMUNE XR 400 mg tablet * Pediatric patients may be dosed using Viramune XR 400 mg or 100 mg tablets. Viramune XR is dosed based on a patients body surface area (BSA). All pediatric patients must initiate therapy with immediate-release Viramune at a dose not to exceed 200 mg per day, administered once daily for the first 14 days because it has been demonstrated to reduce the frequency of rash. This lead-in period is not required if the patient is already on a regimen of twice daily immediate-release formulation * Adverse reactions were similar to those observed in adults. In pediatric patients the incidence of Grade 2 or higher drug-related rash was 1%Information on recommended dosing based on BSA, pharmacokinetics, adverse reactions, and clinical trial * Postmarketing study Antiviral
10/22/2012 Fycompa perampanel Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy *The safety and efficacy was established by 3 double blind, placebo-controlled studies which included 72 pediatric patients 12 - 16 years old exposed to perampanel *The safety and effectiveness in pediatric patients <12 years old have not been established *Most common adverse reactions in adult and pediatric patients include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, gait disturbance, and balance disorder *Information on clinical trials, dosing, adverse reactions, and pharmacokinetics * New drug Anticonvulsant
10/19/2012 Oxtellar XR oxcarbazepine Adjunctive therapy of partial seizures *Safety and effectiveness in pediatric patients ages 6 - 16 years with partial onset seizures is supported by an adequate and well-controlled short term safety and efficacy study in adults that included pharmacokinetic sampling, a pharmacokinetic study in pediatric patients ages 4 - 16 years, and safety and efficacy studies with the immediate-release formulation in adults and pediatric patients * Oxtellar XR is not approved for pediatric patients < 6 years because the size of the tablets are inappropriate for younger children, and has not been studied in patients < 4 years * Information on dosing, adverse reactions, and pharmacokinetics * New dosage form Anticonvulsant
10/18/2012 Cymbalta duloxetine hydrochloride Treatment for Major Depressive Disorder (MDD) *Efficacy was not demonstrated in two 10-week, placebo-controlled trials with 800 pediatric patients with MDD, age 7-17 *Duloxetine has not been studied in pediatric patients less than 7 years *Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. Pediatric patients treated with duloxetine in MDD clinical trials experienced a 0.2 kg mean decrease in weight at 10-weeks, compared with a mean weight gain of approximately 0.6 kg in placebo-treated patients. The proportion of patients who experienced a clinically significant decrease in weight (>3.5%) was greater in the duloxetine group than in the placebo group (11% and 6%, respectively). Subsequently, over the six-month uncontrolled extension period, most duloxetine treated patients trended toward recovery to their expected baseline weight. Perform regular monitoring of weight and growth in children and adolescents treated with an SNRI such as duloxetine *In the 2 pediatric MDD studies, the safety findings were consistent with the known safety and tolerability profile for duloxetine *Information on clinical trial, pharmacokinetics, and juvenile animal study Antidepressant
10/12/2012 Bethkis tobramycin Management of cystic fibrosis patients with P. aeruginosa *Safety and efficacy have been established in adults and children 6 years and older *Safety and efficacy have not been studied in pediatric patients less than 6 years *Use caution in patients with known or suspected auditory or vestibular dysfunction or renal dysfunction. Bronchospasm can occur with inhalation of tobramycin *Information on dose, adverse reactions, and clinical trials *New drug Antibiotic, topical
10/10/2012 Lunesta eszopiclone Attention-Deficit Hyperactivity Disorder associated insomnia *Safety and effectiveness have not been established in pediatric patients*Lunesta failed to demonstrate efficacy in a 12-week controlled study of 483 pediatric patients 6-17 years with insomnia associated with ADHD *Psychiatric and nervous system disorders comprised the most frequent treatment emergent adverse reactions observed with Lunesta versus placebo and included dysgeusia (9% vs. 1%), dizziness (6% vs. 2%), hallucinations (2% vs. 0%) and suicidal ideation (0.3% vs. 0%) * Information on dose, adverse reactions clinical trial and juvenile animal studies Hypnotic
09/27/2012 QUILLIVANT XR methylphenidate hydrochloride Treatment of Attention Deficit Hyperactivity Disorder *Safety and effectiveness have been established in pediatric patients ages 6 - 17 years *Use in pediatric patients 6 - 12 years of age is supported by adequate and well-controlled studies. Use in 12 - 17 year olds is supported by the adequate and well-controlled studies of Quillivant XR in younger pediatric patients and additional pharmacokinetic data in adolescents, with safety information from other methylphenidate products *The long-term efficacy of methylphenidate in pediatric patients has not been established *Safety and efficacy in pediatric patients below the age of 6 years have not been established *Growth should be monitored during treatment with stimulants, including Quillivant XR. Children who are not growing or gaining weight as expected may need to have their treatment interrupted *Information on adverse reactions, pharmacokinetics and clinical tria l*New dosage form CNS Stimulant
09/21/2012 Venofer iron sucrose Treatment of iron deficiency anemia in patients with chronic kidney disease (CKD) *Expanded the indication from adults to pediatric patients 2 years and older* Safety and effectiveness for iron maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied *Safety and effectiveness for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established *Venofer has not been studied in patients < 2 years *The mean Cmax and AUC values were 1.42- and 1.67-fold higher than dose adjusted adult Cmax and AUC values *The most common treatment-emergent adverse reactions were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%) *Information on dosing, adverse reactions, pharmacokinetics, and clinical trial * Postmarketing study Iron Replacement
08/30/2012 Revatio sildenafil Treatment of pulmonary arterial hypertension *Use of Revatio, particularly chronic use, is not recommended in children *In a double-blind, placebo-controlled, dose-ranging study, 234 pediatric patients with PAH 1 - 17 years were randomized based on body weight to three dose levels of Revatio, or placebo, for 16 weeks. No patients died during the 16-week study *In a long-term trial, an increase in mortality with increasing dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH * Information on safety, and clinical trials Peripheral Vasodilator
08/29/2012 Afinitor Disperz everolimus Treatment of subependymal giant cell astrocytoma (SEGA) in patients with tuberous sclerosis complex (TSC) *Approved for patients 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected *The safety and effectiveness of Afinitor Tablets and Afinitor Disperz have not been established in pediatric patients with renal angiomyolipoma with TSC in the absence of SEGA * The effectiveness in pediatric patients with SEGA was demonstrated in two clinical trial * The long term effects of Afinitor on growth and pubertal development are unknown *Information on starting dose, therapeutic drug monitoring, clinical trial, and adverse reactions *New formulation Antineoplastic
08/16/2012 Viread tenofovir disoproxil fumarate Treatment of chronic hepatitis B *Expanded the indication from adults to pediatric patients 12 - < 18 years of age, weighing at least 35k*Safety and efficacy in pediatric patients with chronic hepatitis B < 12 years old or weighing < 35 kg have not been established *In a clinical trial in pediatric patients 12 - <18 years, the mean rate of bone mineral density gain was less in Viread-treated patients compared to placebo* Information on dosing, adverse reactions, and clinical trial *Postmarketing study Antiviral
08/02/2012 Risperdal risperidone Postmarketing study * Information on postmarketing clinical study of a lower than recommended dose for irritability associated with autistic patients in patients 5 to 17 years * Postmarketing study Antipsychotic
06/26/2012 Treanda bendamustine hydrochloride Relapsed or refractory acute leukemia *Effectiveness in pediatric patients has not been established * Treanda was evaluated in a Phase 1/2 trial in pediatric patients with leukemia *The safety profile in pediatric patients was consistent with that seen in adults, and no new safety signals were identified *Information on dosing, clinical trials and PK parameters Antineoplastic
06/14/2012 MENHIBRIX Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine* Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b See Package Insert for new information on biologics Preventive Vaccine
05/30/2012 Torisel temsirolimus Advanced recurrent/refractory solid tumors * Effectiveness in pediatric patients has not been established * Torisel was studied in 59 patients 1 - 17 years and 12 patients 18 to 21 years in a phase 1-2 safety and exploratory pharmacodynamic study * Adverse reactions were similar to those observedd in adults * Information on dosing, clinical trials and PK parameters Antineoplastic
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions * Safety and efficacy assessed in a clinical trial that included 10 patients 8 - 17 years *Safety and efficacy of pancreatic enzyme products with different formulations of the same active ingredient for use in children have been described in medical literature and through clinical experience * Use in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended *High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age *Capsule should be swallowed whole. Capsule and contents should not be crushed or chewed *For patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce and swallowed immediately * Not interchangeable with other pancrelipase products *New drug Pancreatic enzyme
05/12/2012 Voluven 6% Hydroxyethyl Starch 130/0.4 In 0.9% Sodium Chloride Injection* Plasma volume substitute for treatment and prophylaxis of hypovolemia See Package Insert for new information on biologics Coagulant
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis *Safety and effectiveness have been established in 3 clinical trials in patients 12 years and older *Safety and effectiveness in pediatric patients < 12 years have not been established *Intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including Dymista, should be monitored routinely *Information on dosing, adverse reactions, and clinical trials *New drug Antiasthmatic;antiallergy
04/27/2012 Lexiva fosamprenavir Treatment of HIV-1 infection * Expanded indication to include pediatric patients at least 4 weeks - <2 years; previously approved for use in 2  18 years *The PK, safety, tolerability, and efficacy in pediatric patients < 4 weeks have not been established *Dosing of Lexiva plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients <6 months of age; data do not support twice-daily dosing of Lexiva without ritonavir in pediatric patients <2 years *Weight-adjusted apparent clearance was higher in children < 4 years, suggesting that younger children require higher mg per kg dosing of Lexiva *Vomiting and neutropenia were more frequent in pediatrics than in adults. Other adverse reactions were similar to adults * Information on dosing, clinical trials, PK and adverse reactions *New dosage regimen for patients at least 4 weeks - < 6 years; Postmarketing study Antiviral
04/27/2012 Levaquin levofloxacin Treatment and prophylaxis of plague due to Yersinia pestis * Approved for the treatment and prophylaxis of plague due to Yersinia pestis in patients 6 months and older *Efficacy studies could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. Approval of this indication was based on an efficacy study conducted in animals *Safety and effectiveness in pediatric patients < 6 months have not been established *Information on animal study *New indication Antibiotic
03/26/2012 Singulair Oral Granules, Tablets, and Chewable Tablets montelukast Prevention of exercise-induced bronchoconstriction * Expanded indication to include pediatric patients from 6 - 14 years; previously approved for use in 15 years and older *Efficacy for prevention of EIB in patients < 6 years of age has not been established * Information on clinical trial, and dosing * Postmarketing study Antiasthmatic; antiallergy
03/26/2012 Intelence etravirine Treatment of HIV-1 infection in treatment-experienced patients in combination with other antiretroviral agents * Expanded the indication from adults to pediatric patients 6 years and older * Safety and efficacy have not been established in children < 6 years or in treatment naive adult or pediatric patients *Adverse reactions were similar to those observed in adults except for rash which was observed more frequently in pediatric patients (15%) compared to adults (10%)*Intelence tablet(s) should be swallowed whole. Patients who are unable to swallow the Intelence tablet(s) whole may disperse the tablet(s) in a glass of water *Information on dosing in pediatric patients 6 - <18 years and weighing at least 16 kg, dispersing tablet in water, adverse reactions, and clinical trial *Postmarketing study Antiviral
03/23/2012 QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis "Safety and effectiveness in children 12 years and older have been established "Safety and effectiveness in <12 years have not been established "Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving QNASL Nasal Aerosol "The potential for QNASL Nasal Aerosol to cause reduction in growth velocity in susceptible patients or when given at higher than recommended dosages cannot be ruled out "Information on safety, adverse events and clinical trials "New dosage form Anti-inflammatory, topical
03/14/2012 Natazia estradiol valerate and estradiol valerate/dienogest Treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception "Safety and efficacy have been established in women of reproductive age. Safety and efficacy for post pubertal adolescents < 18 are expected to be the same as for 18 years and older "Use of this product before menarche is not indicated "New indication Contraceptive
03/01/2012 Ultresa pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions "Safety and efficacy assessed in 2 studies that included patients 7--17 years "Safety and efficacy of pancreatic enzyme products with different formulations of the same active ingredient for use in children have been described in medical literature and through clinical experience "High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age " Adverse reactions similar to adults "Use in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended "Children > 12 months and < 4 years, weighing < 14 kg and children e 4 years, weighing < 28 kg should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children "Capsule should be swallowed whole. Capsule and contents should not be crushed or chewed. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce and swallowed immediately "Information on dosing and clinical studies "Not interchangeable with other pancrelipase products "New drug Pancreatic enzyme
02/29/2012 FluMist Quadrivalent Influenza Vaccine Live, Intranasal* Active immunization for the prevention of disease caused by influenza See Package Insert for new information on biologics Vaccine
02/09/2012 Famvir famciclovir Recurrent herpes labialis "Efficacy has not been established in pediatric patients for the treatment of recurrent herpes labialis "Information on an open label PK, safety and efficacy study in children 12 to <18 years with recurrent herpes labialis added to Pediatric Use subsection of labeling"Postmarketing study Antiviral
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations "Safety and effectiveness in children 6 months and older have been established "Safety has not been established in pediatric patients < 6 months. Sklice Lotion is not recommended in pediatric patients <6 months of age because of the potential increased systemic absorption and risk of ivermectin toxicity" Information on dosage and administration, adverse reactions, pharmacokinetics and clinical trials"New drug Pediculocide, topical
01/25/2012 TISSEEL Fibrin Sealant* Hemostasis: An adjunct to hemostasis in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: An adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies See Package Insert for new information on biologics Wound healing
01/18/2012 Viread tenofovir disoproxil fumarate Treatment of HIV infection in combination with other antiretroviral agents *Viread tablets: Expanded the indication from adults to pediatric patients 2 - < 12 years, weighing greater than or equal to 17 kg, who can swallow an intact tablet; tablet previously approved for use in 12 years and older * Viread Oral Powder: Expanded the indication from adults to pediatric patients 2 years of age and older * Safety and effectiveness in patients <2 years have not been established *Viread oral powder should be mixed in a container of soft food not requiring chewing (e.g., applesauce, baby food, yogurt) and ingested immediately to avoid a bitter taste *Adverse reactions were similar to those observed in adults *Postmarketing study, new dosage form Antiviral
12/21/2011 Isentress raltegravir In combination with other antiretroviral agents for the treatment of HIV-1 infection *Isentress Chewable tablets: Expanded indication from adults to pediatric patients 2 - < 12 years and weighing at least 10kg *Isentress Tablets: Expanded indication from adults to pediatric patients 6-18 years *Safety and effectiveness in patients <2 years have not been established*Because the formulations are not bioequivalent, do not substitute chewable tablets for the 400 mg film-coated tablet *Safety profile similar to that observed in adults *Information on dosing, adverse reactions, clinical trial and PK parameters *New dosage form Antiviral
12/16/2011 Keppra levetiracetam Adjunctive therapy in the treatment of partial onset seizures * Expanded indication to include pediatric patients from 1 month - <4 years; previously approved for use in 4 years and older* In pediatric patients 1 month - < 4 years of age, 17% experienced psychotic symptoms compared to 5% on placebo; irritability was reported in 11.7% of the Keppra-treated patients compared to 0% of placebo patients* Information on dosing, clinical trial, adverse reactions Anticonvulsant
12/16/2011 Maxalt and Maxalt-MLT rizatriptan Treatment of migraine * Expanded indication to include pediatric patients from 6 - 17 years. Safety and effectiveness in this age group was established in an adequate and well-controlled trial.* Safety and effectiveness in pediatric patients under 6 years of age have not been established.* Efficacy and safety of treatment with more than one dose of Maxalt within 24 hours in patients 6 to 17 years of age have not been established* Maxalt should not be prescribed to propranolol-treated pediatric patients who weigh < 40 kg (88 lb)* The incidence of adverse reactions in the pediatric clinical trial was similar between treatment and placebo groups. The adverse reaction pattern in pediatric patients is expected to be similar to adults* Hallucination, abnormal coordination, disturbance in attention, and presyncope occurred infrequently in pediatric patients in the clinical trial * Information on dosing, adverse reactions, clinical trial, and overdose Antimigraine
12/16/2011 Prezista darunavir Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older and weighing at least 10 kg * Expanded indication to pediatric patients 3 years and older weighing at least 10 kg; previously approved for use in 6 years and older* Do not use in pediatric patients < 3 years of age* Information on dosing, adverse reactions, pharmacokinetics and clinical trial* New formulation Antiviral
12/15/2011 Nexium esomeprazole Erosive esophagitis due to acid-mediated gastroesophageal reflux disease * Expanded age range to include pediatric patients 1 month to <1 year. Previously approved in 1-17 years. Use in 1 month to <1 year is supported by extrapolation of studies for adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients * Safety and effectiveness have not been established in neonates* Information on weight-based dosing, adverse reactions, clinical study Antiulcerative
12/14/2011 Advate Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method* Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A See Package Insert for new information on biologics Antihemophilic Factor
11/10/2011 HEMACORD hematopoietic progenitor cells, cord blood* For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment See Package Insert for new information on biologics Somatic Cell
11/09/2011 Chantix varenicline Smoking cessation * Safety and effectiveness of Chantix in pediatric patients have not been established; Chantix is not recommended for use in patients < 18 years of age* Information on single and multiple-dose pharmacokinetics of varenicline have been investigated in pediatric patients 12 - 17 years * Postmarketing study Smoking cessation

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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.

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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