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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 665
n = 601 with New Pediatric Studies; n = 64 with No New Pediatric Studies
BPCA only = 171; BPCA + PREA = 88; PREA only = 356; Rule = 49; None = 1

Pediatric Labeling Changes as of December 310, 2016

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:  665
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
12/22/2016 Lyrica pregabalin Fibromyalgia *Safety and efficacy in pediatric patients have not been established. *A 15-week, placebo-controlled trial was conducted with 107 pediatric patients with fibromyalgia, ages 12 through 17 years . *The primary efficacy endpoint of change from baseline to Week 15 in mean pain intensity showed numerically greater improvement for the pregabalin-treated patients compared to placebo-treated patients, but did not reach statistical significance. *The most frequently observed adverse reactions in the clinical trial included dizziness, nausea, headache, weight increased, and fatigue. The overall safety profile in adolescents was similar to that observed in adults with fibromyalgia. *Postmarketing study. Antidepressant
12/22/2016 Lumason Sulfur Hexafluoride Lipid-Type A Microspheres Evaluation of suspected or known vesicoureteral reflux in pediatric patients *Effectiveness in pediatric patients has been established for use in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux from two published studies comprising a total of 411 pediatric patients. *Safety of intravesical use of Lumason was based on evaluation of published literature involving use of Lumason in over 6000 pediatric patients. No adverse reactions were reported. *Information on published studies. *New indication. Medical Imaging
12/16/2016 Ryzodeg 70/30 insulin degludec/insulin aspart Improve glycemic control in type 1 and type 2 diabetes mellitus in pediatric patients 1 year and older *Expanded indication from adults to pediatric patients 1 year and older. *Use in pediatric patients 1 year and older with type 1 and type 2 diabetes mellitus is supported by evidence from an adequate and well-controlled study and a pharmacokinetic study. Use in pediatric patients 1 year and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 1 year old. *In pediatric patients 1 year and older with switching from other insulin therapies, start Ryzodeg 70/30 at a reduced dose to minimize the risk of hypoglycemia. *In pediatric patients inject Ryzodeg 70/30 subcutaneously once daily with any main meal. *Not recommended for pediatric patients requiring less than 5 units of Ryzodeg 70/30 daily. *Adverse reactions similar to those observed in adults. *Information on dosing, PK, and clinical trials. *Postmarketing study. Antidiabetic
12/16/2016 Tresiba insulin degludec Improve glycemic control in type 1 and type 2 diabetes mellitus in pediatric patients 1 year and older *Expanded indication from adults to pediatric patients 1 year and older. *Use in pediatric patients 1 year and older with type 1 and type 2 diabetes mellitus is supported by evidence from an adequate and well-controlled study and a pharmacokinetic study. Use in pediatric patients 1 year and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 1 year old. *In pediatric patients 1 year and older with switching from other insulin therapies, start Ryzodeg 70/30 at a reduced dose to minimize the risk of hypoglycemia. *In pediatric patients inject Ryzodeg 70/30 subcutaneously once daily with any main meal. *Not recommended for pediatric patients requiring less than 5 units of Ryzodeg 70/30 daily. *Adverse reactions similar to those observed in adults. *Information on dosing, PK, and clinical trials. *Postmarketing study. Antidiabetic
12/14/2016 Eucrisa ointment crisaborole Mild to moderate atopic dermatitis in patients 2 years of age and older * Safety and effectiveness have been established in pediatric patients age 2 years and older for topical treatment of mild to moderate atopic dermatitis. * Use in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 28-day trials which included 1,313 pediatric patients 2 years and older. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. * Information on PK, adverse events in adults and children, and clinical trial. *New drug.
11/25/2016 Renvela sevelamer carbonate Control of serum phosphorus in children 6 years of age and older with chronic kidney disease on dialysis *Expanded the indication from adults to pediatric patients ages 6 years and older. *Renvela has not been studied in pediatric patients below 6 years of age. *Most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. *Information on starting dose and titration, adverse reactions and clinical trial. *Postmarketing study Phosphate binder
11/18/2016 FluLaval Influenza Virus Vaccine* Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine in persons aged 6 months and older See Package Insert for new information on biologics Preventive Vaccine
11/18/2016 FluLaval Quadrivalent Influenza Virus Vaccine* Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine in persons aged 6 months and older See Package Insert for new information on biologics Preventive Vaccine
11/11/2016 Naftin naftifine hydrochloride Tinea corporis in pediatric patients 2 years and older *Expanded the indication down to pediatric patients 2 years and older; previously approved in pediatric patients 12 years and older. *Safety and effectiveness in the treatment of tinea corporis in pediatric patients less than 2 years of age have not been established. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, pharmacokinetic parameters, and clinical trials. *Postmarketing study Antifungal, topical
11/04/2016 Enbrel etanercept Chronic moderate to severe plaque psoriasis (PsO ) in patient who are candidates for systemic therapy or phototherapy patients ages 4 to 17 years *Expanded the indication from adults to pediatric patients 4 to 17 years. *Enbrel has been studied in 211 pediatric patients with moderate to severe PsO aged 4 to 17 years. * Enbrel has not been studied in children less than 4 years of age with PsO. * Adverse events were similar to those observed in adults. *Information on dosing, PK, adverse reactions, and clinical trial. * New indication. Immunosuppressant
11/04/2016 Selzentry maraviroc Treatment of only CCR5-tropic HIV-1 infection in patients 2 years of age and older weighing at least 10 kg *Expanded the indication from adults to pediatric patients 2 years of age and older weighing at least 10 kg. *Safety, pharmacokinetic profile, and antiviral activity were evaluated in treatment-experienced, CCR5-tropic, HIV-1-infected pediatric patients 2 to less than 18 years weighing at least 10 kg in an open-label, multicenter clinical trial. *The pharmacokinetics, safety, and efficacy in patients younger than 2 years have not been established. *Selzentry is contraindicated in pediatric patients with severe renal impairment or End Stage Renal Disease on regular hemodialysis who are receiving potent CYP3A inhibitors. *There are insufficient data to make dosing recommendations for use in pediatric patients concomitantly receiving noninteracting medications and weighing less than 30 kg or in pediatric patients concomitantly receiving potent CYP3A inducers without a potent CYP3A inhibitor. *The most common adverse reactions in treatment-experienced pediatric patients are vomiting, abdominal pain, diarrhea, nausea, and dizziness. *Information on recommended dosing, Pk parameters and clinical trial. *New oral solution and two lower dose strength tablets. *Postmarketing study Antiviral
10/18/2016 Zemplar paricalcitol Secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3, 4 and 5 in pediatric patients 10 to 16 years *Safety and effectiveness have been established in pediatric patients 10 to 16 years of age. *Use in this age group is supported by evidence from adequate and well controlled studies in adults with CKD, a 12-week double-blind placebo-controlled randomized multicenter study in 36 pediatric patients 10 to 16 years of age with CKD Stages 3 and 4, and safety data from a 12-week open-label single-arm multicenter study in 13 pediatric patients 10 to 16 years of age with CKD Stage 5 receiving peritoneal dialysis or hemodialysis. *Safety and effectiveness in pediatric patients under the age of 10 years have not been established. *Adverse reactions were similar to those reported in adults. *Information on dosing, pharmacokinetic parameters, and clinical trial. *Postmarketing study
10/14/2016 Varibar Pudding barium sulfate Evaluate the oral and pharyngeal function and morphology in adults and pediatric patients 6 months of age and older * Efficacy in pediatric patients above 6 months of age is based on successful opacification of the pharynx during modified barium swallow examinations. * Safety and dosing recommendations in pediatric patients above 6 months of age are based on clinical experience. * Varibar Pudding is contraindicated in pediatric patients with tracheo-esophageal fistula. * Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use. *Information on dosing. * New drug
10/06/2016 Pertzye pancrelipase Postmarketing study * Labeling updated to include new dosage strength of 4,000 USP lipase units. * Infants may be given 4,000 lipase units (one capsule) per 120 mL of formula or breastfeeding. Do not mix Pertzye capsule contents directly into formula or breast milk prior to administration. * New dosage form Pancreatic enzyme
09/27/2016 Avelox moxifloxacin hydrochloride Complicated intra-abdominal infections (cIAI) *Safety and efficacy in pediatric patients for tbe treatment of clAl has not been demonstrated. *Pediatric patients 3 months to <18 years of age (N=451) were enrolled in a single randomized, double blind, active controlled trial in clAl including appendicitis with perforation, abscesses and peritonitis. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, clinical trial. Antibiotic
09/13/2016 CUVITRU Immune Globulin Subcutaneous (Human), 20% Liquid* Indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older See Package Insert for new information on biologics
09/09/2016 Q-Pan Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted* Prophylaxis of influenza A (H5N1) in children (6 months and older) and adults See Package Insert for new information on biologics Preventive Vaccine
09/09/2016 Noxafil posaconazole Postmarketing study *In a study of 136 neutropenic pediatric patients 11 months to less than 18 years treated with posaconazole oral suspension, the exposure was attained in approximately 50% of patients instead of the pre-specified 90% of patients. *Postmarketing study. Antiviral
09/02/2016 Canasa Suppositories mesalamine Mildly to moderately active ulcerative proctitis *Safety and effectiveness in pediatric patients have not been established. *Canasa was evaluated for the treatment of ulcerative proctitis in a 6-week, open-label, single-arm study in 49 patients 5 to 17 years of age. *Adverse reactions were similar to those seen in adult patients. *Information on adverse reactions, and clinical trial. *Postmarketing study.
08/16/2016 Kapvay clonidine Postmarketing study *In studies in juvenile rats, clonidine hydrochloride alone or in combination with methylphenidate had an effect on bone growth at clinically relevant doses and produced a slight delay in sexual maturation in males at 3 times the maximum recommended human dose (MRHD) for clonidine and methylphenidate. *Juvenile rat studies also showed a decrease in bone mineral density, mineral content, and decreased femur length. Decreased body weight was also observed. *Postmarketing study. Non-stimulant ADHD treatment
07/29/2016 Dysport abobotulinumtoxinA Treatment of lower limb spasticity in pediatric patients 2 years of age and older *Indicated for the treatment of lower limb spasticity in pediatric patients 2 years and older. *Safety and effectiveness in pediatric patients with lower limb spasticity below 2 years of age have not been evaluated. *Safety and effectiveness of Dysport injected into proximal muscles of the lower limb for the treatment of spasticity in pediatric patients has not been established. *The most commonly observed adverse reactions were upper respiratory tract infection, nasopharyngitis, influenza, pharyngitis, cough and pyrexia. *Information on dosing, preparation and administration, adverse reactions, and clinical trial. *New indication. neuromuscular blocking agent
07/12/2016 Effient prasugrel Vaso-occlusive crises in pediatric patients with sickle cell disease *Safety and effectiveness in pediatric patients have not been established. *In a randomized, placebo-controlled trial, the primary objective of reducing the rate of vaso-occlusive crisis in pediatric patients, aged 2 to less than 18 years, with sickle cell anemia was not met.
07/08/2016 Dexilant dexlansoprazole Healing of erosive esophagitis (EE), maintenance of healed EE and relief of heartburn, and treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD) in 12 to 17 years *Safety and effectiveness of Dexilant capsules have been established in pediatric patients 12 to 17 years for the healing of all grades of EE. *The safety and effectiveness of Dexilant capsules and Dexilant SoluTab have been established in pediatric patients 12 to 17 years for the maintenance of healed EE and relief of heartburn, and treatment of heartburn associated with symptomatic non-erosive GERD. *Use in this age group is supported by evidence from adequate and well-controlled studies of Dexilant capsules in adults with additional safety, efficacy and pharmacokinetic data in pediatric patients 12 to 17 years. *Safety and effectiveness have not been established in pediatric patients less than 12 years. *Use of Dexilant is not recommended for symptomatic non-erosive GERD in pediatric patients less than 1 year because studies in this class of drugs have not demonstrated efficacy. *Adverse reactions similar to those observed in adults. *Information on dosing, adverse reactions, clinical trials. *Postmarketing study. Antiulcerative
07/06/2016 Xolair omalizumab Moderate to severe persistent asthma in pediatric patients 6 to 11 years of age *Safety and efficacy of Xolair for asthma were evaluated in 2 trials in 926 (Xolair 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma. *Safety and efficacy in pediatric patients with asthma below 6 years of age have not been established. *Information on dosing, immunogenicity, adverse reactions, clinical trials. *Postmarketing study. Antiasthmatic
06/30/2016 Kovanaze Nasal Spray tetracaine HCl and oxymetazoline HCl Regional anesthesia when performing a restorative procedure on teeth 4-13 and A-J in adults and children who weigh 40 kg or more *Approved in adults and children who weigh 40 kg or more *Kovanaze has not been studied in pediatric patients under 3 years and is not advised for use in pediatric patients weighing less than 40 kg because efficacy has not been demonstrated in these patients *Information on adverse reactions in adults and pediatric patients, clinical trial, PK * New drug
06/09/2016 Tivicay dolutegravir Treatment naïve or treatment experienced INSTI-naïve pediatrics patients weighing at least 30 kg to less than 40 kg *Expanded the indication to pediatrics patients weighing at least 30 kg; previously approved in 12 years and older weighing at least 40 kg * Safety and efficacy have not been established in pediatric patients weighing less than 30 kg or in any pediatric patients who are INSTI-experienced *Adverse reactions were similar to those observed in adults *Information on dosing, PK, and adverse reactions *Postmarketing study Antiviral
05/27/2016 Teflaro Injection ceftaroline fosamil Acute Bacterial Skin and Skin Structure Infections (ABSSI) and Community Acquired Bacterial Pneumonia (CABP) in pediatric patients 2 months to less than 18 years *Safety and effectiveness of Teflaro in the treatment of ABSSI and CABP have been established in pediatric patients 2 months to less than 18 years. *Use of Teflaro in these age groups is supported by evidence from adequate and well-controlled studies of Teflaro in adults with additional pharmacokinetic and safety data from pediatric trials. *Safety and effectiveness in pediatric patients below the age of 2 months have not been established as no data are available. *Safety findings were similar to those seen in the adult studies. *Information on dosing, PK , and adverse reactions. *Postmarketing study Antibiotic
05/27/2016 Ativan Injection lorazepam Status epilepticus *Safety and effectiveness for status epilepticus have not been established in pediatric patients. *A randomized, double-blind, superiority-design clinical trial of Ativan versus intravenous diazepam in 273 pediatric patients ages 3 months to 17 years failed to establish efficacy for the treatment of status epilepticus. *Information on adverse reactions, and clinical trial Anticonvulsant
05/25/2016 AFSTYLA Antihemophilic Factor (Recombinant), Single Chain* Indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes, (2) Routine prophylaxis to reduce the frequency of bleeding episodes, and (3) Perioperative management of bleeding See Package Insert for new information on biologics Antihemophilic Factor
05/23/2016 Flucelvax Quadrivalent Influenza Vaccine* For active immunization of children and adolescents 4 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine See Package Insert for new information on biologics Preventive Vaccine
05/23/2016 Flucelvax Influenza Vaccine* For active immunization of persons 4 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine See Package Insert for new information on biologics Preventive Vaccine
04/29/2016 Fycompa perampanel Adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy 12 years of age and older and as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older * New Fycompa oral suspension has comparable bioavailability to Fycompa tablets under steady state. Both formulations may be used interchangeably. *Measure oral suspension using provided adaptor and dosing syringe. * Information on administration of oral suspension. *New formulation. Anticonvulsant
04/29/2016 Otovel Otic Solution ciprofloxacin and fluocinolone acetonide Treatment of acute otitis media with tympanostomy tubes in pediatric patients 6 months and older * Approved for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients aged 6 months and older, * Information on dosing, and clinical trials. * New drug. antibiotic/anti-inflammatory
04/29/2016 Entocort EC budesonide Treatment of mild to moderate active Crohn's disease in patients 8 years of age and older, and maintenance of remission in Crohn’s disease in patients ages zero to 17 years of age Mild to moderate active Crohn's disease * Safety and effectiveness have been established in pediatric patients 8 to 17 years who weigh more than 25 kg for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon. * Use in this age group is supported by evidence from adequate and well controlled studies of Entocort EC in adults, with additional data from 2 clinical studies in 149 pediatric patients treated up to 8 weeks and one pharmacokinetic study in 8 pediatric patients. * Safety and effectiveness have not been established in pediatric patients less than 8 years of age. Maintenance of remission in Crohn’s disease * Safety and effectiveness have not been established in pediatric patients for the maintenance of clinical remission of mild to moderate Crohn’s disease. * An open-label study to evaluate the safety and tolerability as maintenance treatment in pediatric patients aged 5 to 17 years did not establish the safety and efficacy of maintenance of clinical remission. * Safety profile is similar to safety profile observed in adults and no new safety concerns were identified. * Systemic corticosteroids, including Entocort EC, may cause a reduction of growth velocity in pediatric patients. * Pediatric patients with Crohn’s disease have a 17% higher mean systemic exposure and cortisol suppression than adults with Crohn’s disease. *Information on dosing, safety, clinical trials and PK. *Postmarketing study. Anti-inflammatory
04/28/2016 ProAir RespiClick albuterol sulfate Asthma in pediatric patients between the ages 4 to 11 years * Expanded the indication down to pediatric patients 4-11 years; previously approved in 12 years and older. * Safety and effectiveness in pediatric patients below the age of 4 years have not been established. * Information on dosing, adverse reactions, and clinical trials. * Postmarketing study Antiasthmatic
04/27/2016 Gadavist gadobutrol Evaluation of known or suspected supra-aortic or renal artery disease in adult and pediatric patients * Approved for use in adults and pediatric patients, including term neonates, to evaluate known or suspected supra-aortic or renal artery disease. * Information on clinical trials. * New indication. Medical Imaging
04/14/2016 Trumenba Meningococcal Group B Vaccine * Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B See Package Insert for new information on biologics Vaccine
04/04/2016 Descovy emtricitabine and tenofovir alafenamide Treatment of HIV-1 infection in adults and pediatric patients 12 years of age or older * Efficacy and safety of Descovy was established in pediatric patents aged 12 years old with body weight greater than or equal to 35 kg. * Safety and effectiveness in pediatric patients less than 12 years or less than 35 kg have not been established. * Assessment of Bone Mineral Density should be considered for adults and pediatric patients treated with Descovy who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. * Information on dosing, clinical trial and PK. * New drug. Antiviral
03/31/2016 Lumason Sulfur Hexafluoride Lipid-Type A Microspheres Ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients * Effectiveness in pediatric patients has been established for use in ultrasonography of the liver for characterization of focal liver lesions from adequate and well controlled trials in adult patients and a clinical study of 44 pediatric patients. Safety was based on evaluation of published literature involving use of Lumason in over 900 pediatric patients. Non-fatal anaphylaxis was reported in one pediatric patient. * New indication Medical Imaging
03/23/2016 Cinqair reslizumab Asthma in patients 12 to 17 years * The safety and effectiveness in pediatric patients have not been established. * CINQAIR was evaluated in 39 patients aged 12 to less than 18 years with asthma in two 52-week exacerbation studies and one 16-week lung function study. In these studies, the asthma exacerbation rate was higher in adolescent patients treated with CINQAIR than placebo. * Information on clinical trials. * New drug Antiasthmatic
03/18/2016 Anthim obiltoxaximab Treatment of inhalational anthrax in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax * The effectiveness in adults and pediatric patients is based solely on efficacy studies in animal models of inhalational anthrax. * There have been no studies of safety or PK of ANTHIM in the pediatric population. * Information on dosing. * New drug
03/18/2016 OraVerse Injection phentolamine mesylate Reversal of soft-tissue anesthesia * Expanded indication down to pediatric patients 3 years and older; previously approved in 6 years and older. * Safety and efficacy have not been established in patients younger than 3 years. • Information on dosing and PK. * Postmarketing study
03/16/2016 KOVALTRY Antihemophilic Factor (Recombinant), Full Length* "Indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) 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
03/10/2016 Truvada emtricitabine/tenofovir disoproxil fumarate Treatment of HIV-1 infection in pediatric patients weighing at least 17 kilograms * Expanded the indication from pediatric patients 12 years and older down to pediatric patients weighing at least 17 kg. * Truvada should only be administered to HIV-1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a whole tablet. *Truvada has not been evaluated for use in pediatric patients weighing less than 17 kg. *Postmarketing study Antiviral
03/01/2016 Odefsey emtricitabine, rilpivirine, and tenofovir alafenamide Treatment of HIV-1 infection in patients 12 years of age and older * Safety and efficacy of Odefsey was established in pediatric patients 12 years and older weighing 35 kg or more. * Use of Odefsey in this age group is supported by adequate and well-controlled studies in adults with HIV-1 infection, and by 2 pediatric studies in 59 pediatric patients 12 to < 18 years. * Safety and efficacy have not been established in pediatric patients less than 12 years of age or weighing less than 35 kg. * Safety was similar to that observed in adults. * Information on clinical trials, adverse reactions. * New drug Antiviral
02/29/2016 Tetracaine Hydrochloride Ophthalmic Solution tetracaine hydrochloride For use in procedures requiring a rapid and short-acting topical ophthalmic anesthetic * Approved for use in adults and pediatric patients. * Safety in the pediatric population has been demonstrated in clinical trials. Efficacy for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population. * Information on dosing. * New drug. Antibiotic, topical
02/24/2016 Aczone Gel 7.5% dapsone Treatment of acne vulgaris in patients 12 years of age and older * Approved in adults and pediatric patients 12 years and older. * Safety and efficacy was evaluated in 1066 patients 12-17 years old. * Safety and effectiveness have not been established in pediatric patients below the age of 12 years. * Safety was similar to the vehicle control group. * Information on clinical trials, and adverse reactions in adults and pediatric patients 12 and older. * New Drug Anti-inflammatory, topical
02/23/2016 Complera emtricitabine/rilpivirine/tenofovir disoproxil fumarate Treatment of HIV-1 infection * Extended the indication from adults to pediatric patients in 12 to less than 18 years. *Safety and efficacy have not been established in pediatric patients less than 12 years or weighing less than 35 kg. * Pediatric trials have not been conducted using the emtricitabine, rilpivirine, tenofovir disoproxil fumarate fixed-dose combination tablets. Pediatric information is based on trials conducted with the individual entities. * Information on pharmacokinetics, and dosing. * Postmarketing study. Antiviral
02/03/2016 Prilosec omeprazole Short term treatment of erosive esophagitis due to gastroesophageal reflux disease in patients 1 month to less than 1 year of age * Safety and effectiveness have been established in pediatric patients 1 month to less than 1 year of age. * Use in this population is supported by adequate and well-controlled studies in adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients. * Safety and efficacy have not been establish in patients less than 1 month of age for any indication. *Adverse reactions frequently reported in the 1 month to <1 year age group include respiratory adverse reactions (42%), and otitis media (22%). Information on dosing, PK, adverse reactions. *Postmarketing study Antiulcerative
01/27/2016 Adzenys XR-ODT amphetamine Attention Deficit Hyperactivity Disorder in pediatric patients 6 to 17 * Safety and effectiveness have been established in pediatric patients 6 to 17 years in three clinical trials of up to 4 weeks in duration * Safety and efficacy in pediatric patients younger than 6 years of age have not been established. *Growth should be monitored during treatment with stimulants, including Adzenys XR-ODT, in pediatric patients 6 to 17 years who are not growing or gaining weight as expected because they may need to have their treatment interrupted. *Pediatric patients ages 6 to 12 years: Most common adverse reactions were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. Pediatric patients ages 13 to 17 years: Most common adverse reactions were loss of appetite, insomnia, abdominal pain, weight loss, and nervousness. *Information on dosing, adverse reactions, and clinical trials *New dosage form CNS Stimulent

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Products in this table are listed by labeling change date in descending order and fell within the scope of the Pediatric Rule, the Best Pharmaceuticals for Children Act (BPCA), and the Pediatric Research Equity Act (PREA), and contain new pediatric information. All other labeling changes are based on information from clinical trials in pediatric patients. This list only serves to highlight key information affecting the pediatric population at the time the particular application was approved resulting from the studies performed for the Pediatric Rule, BPCA and PREA. Note: Drugs with *** had a pediatric labeling change in response to BPCA after the Written Request expired.

Helpful Links:
Drug and therapeutic biological labeling:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Biological labeling and reviews:
http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122938.htm

BPCA 2002 Review Summaries:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm161894.htm

**The Protopam labeling change is an exception. The labeling change is included in the Pediatric Labeling Changes Table even though it was not triggered by BPCA or PREA.

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