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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 538
n = 489 with New Pediatric Studies; n = 49 with No New Pediatric Studies
BPCA only = 161; BPCA + PREA = 73; PREA only = 254; Rule = 49; None = 1

Pediatric Labeling Changes as of November 17,2014

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:  538
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
05/28/2009 Besivance besifloxacin ophthalmic suspension Treatment of bacterial conjunctivitis * Efficacy in pediatric patients 1 year and older has been demonstrated in controlled clinical trials * Safety and effectiveness in infants < 1 year of age have not been established * There is no evidence that the ophthalmic administration of quinolones has any effect on weight bearing joints * Information on AE profile and clinical study * New drug Antibiotic, topical
05/08/2009 Lamictal lamotrigine Adjunctive treatment for partial seizures in pediatric patients 1  24 months * Safety and effectiveness as adjunctive treatment for partial seizures were not demonstrated in a small randomized, double-blind, placebo-controlled, withdrawal study in pediatric patients 1 - 24 months * Immediate release tablets were associated with an increased risk for infectious adverse reactions including bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection (Lamictal 37%, Placebo 5%), and respiratory adverse reactions including nasal congestion, cough, and apnea. (Lamictal 26%, Placebo 5%) Anticonvulsant
05/01/2009 Cetraxal ciprofloxacin otic solution Treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus * Efficacy in pediatric patients 1 year and older has been demonstrated in controlled clinical trials * Safety and effectiveness in infants < 1 year have not been established * There is no evidence that the otic administration of quinolones has any effect on weight bearing joints * Information on AE profile and clinical study * New dosage form Antibiotic, topical
04/30/2009 Axert almotriptan Acute treatment of pediatric migraine in adolescent patients age 12-17 years * Safety and effectiveness established in patients 12  17 years. Efficacy on migraine associated symptoms (nausea, photophobia and phonophobia) was not established. * Safety and effectiveness in pediatric patients < 12 years have not been established * The most common adverse events were dizziness, somnolence, headache, paresthesia, nausea and vomiting. Safety and tolerability similar to adults. * Information on dosing, adverse events, PK parameters, clinical study * Patient population altered Antimigraine
04/30/2009 Creon pancrelipase Exocrine pancreatic insufficiency due to cystic fibrosis or other conditions * Safety and efficacy assessed in a study that included patients 12-18 years * Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase containing the same active ingredient. * High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age * AEs similar to adults * Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce * Information on dosing and clinical study * Not interchangeable with other pancrelipase products * New drug Pancreatic enzyme
04/14/2009 Suprane desflurane Safety study of 2 agents used for maintenance of anesthesia in non-intubated patients * Postmarketing Reports subsection added to the Adverse Events section of labeling, including reports of cardiac disorders. * Postmarketing reports are voluntary; it is not possible to estimate frequency or causality to drug exposure. Anesthetic agent
04/09/2009 Ulesfia Lotion, 5% benzyl alcohol Treatment of head lice * Safety and effectiveness established in pediatric patients 6 months and older * Safety in pediatric patients < 6 months has not been established. * Not recommended in pediatric patients < 6 months due to potential for increased systemic absorption * Neonates are at risk of gasping syndrome due to benzyl alcohol * Adverse events similar to those observed in adults * Information on dosing and administration, warnings and precautions, adverse events, PK parameters, and clinical studies * New drug Pediculocide, topical
03/19/2009 Lexapro escitalopram oxalate Major depressive disorder in adolescents * Safety and effectiveness have been established in adolescents 12 to 17 years for the treatment of MDD. Maintenance efficacy is supported from extrapolation of data from adult studies along with comparisons with racemic citalopram pharmacokinetic parameters in adults and adolescents. * Safety and effectiveness have not been established in pediatric patients <12 years with MDD * Safety and effectiveness have not been established in pediatric patients less than 18 years of age with Generalized Anxiety Disorder * Adverse events generally similar to those observed in adults * Information on dosing, adverse events, PK parameters, and clinical studies * Patient population altered Antidepressant
12/19/2008 Casodex bicalutamide Gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty (testotoxicosis) * Safety and effectiveness have not been established in pediatric patients * Bicalutamide was studied in combination with anastrozole in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of testotoxicosis in patients e2 years * Of the 14 patients exposed to study treatment, 13 had at least one adverse event. Adverse reactions considered possibly related to bicalutamide included gynecomastia (43%), central precocious puberty (14%), breast tenderness (14%), breast pain (7%), asthenia (7%), increased alanine aminotransferase (7%), increased aspartate aminotransferase (7%), and musculoskeletal chest pain (7%). Headache was the only adverse reaction considered possibly related to anastrozole * Information on clinical studies, AEs, and PK parameters Androgen blocker
12/19/2008 Ziagen abacavir HIV infection * Provided new scored tablet for use in pediatric patients weighing >14 kg who can swallow tablets * New dosing regimen Antiviral
12/18/2008 Prezista darunavir Treatment of HIV infection in pediatric patients 6 years and older when co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents * Extended indication from adults to pediatric patients 6 years and older * Safety and effectiveness in pediatric patients 3 to < 6 years of age have not been established * Do not administer in pediatric patients below 3 years of age * Do not administer Prezista/rtv once daily in pediatric patients * Dosing for patients 6 to < 18 years and weighing at least 44 lbs (20 kg) is based on body weight not to exceed adult dose * AE similar to those seen in adults * Information on dose, Aes, PK parameters, lab abnormalities, and clinical study Antiviral
12/17/2008 Epiduo adapalene and benzoyl peroxide Topical treatment of acne vulgaris in patients 12 years of age and older * Safety and effectiveness established in patients 12 years of age and older * Safety and effectiveness in pediatric patients under the age of 12 have not been established * New drug Antiacne, topical
12/11/2008 PegIntron Peginterferon alfa-2b Co-administered with ritonavir to treat chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with interferon alpha * Safety and efficacy established in pediatric patients 317 years of age * Safety and effectiveness in patients < 3 years have not been established. * Dosing for pediatric patients is determined by body surface area for peginterferon alfa-2b and by body weight for ritonavir * An open-label study in patients 3 - 17 years showed weight and height gain of pediatric patients treated with combination therapy lags behind that predicted by population data while on treatment. * Adverse events similar to those observed in adults. Most common pediatric adverse events were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, vomiting * Information on PK parameters, and clinical study * New indication Antiviral
12/05/2008 Arimidex anastrozole Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty * Efficacy has not been demonstrated in clinical studies of anastrozole in the treatment of pubertal gynecomastia in adolescent boys 11-18 years and in the treatment of precocious puberty in girls with McCune-Albright Syndrome 2 to < 10 years * Information on clinical studies, AEs, and PK parameters Estrogen lowering agent
11/14/2008 Neulasta Pefilgrastim Decrease the incidence of infection in pediatric patients with sarcoma * Safety and effectiveness in pediatric patients have not been established * Safety and PK were studied in 37 pediatric patients with sarcoma * Information added to Pediatric Use Hematopoietic
10/28/2008 Prevacid lansoprazole Symptomatic GERD in infants * Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age * AE profile similar to that observed in adults* Information on PK parameters in neonates to < 1 year, and clinical studies Antiulcerative
10/24/2008 Apidra insulin glulisine recombinant Diabetes Mellitus * Extended indication from adults to pediatric patients 4 years and older with type 1 diabetes * Has not been studied in pediatric patients less than 4 years with type 1 diabetes and in pediatric patients with type 2 diabetes * Pediatric patients had a higher incidence of severe symptomatic hypoglycemia compared to adults in the clinical study * New indication Antidiabetic
10/21/2008 Acanya Gel clindamycin/ benzoyl peroxide combination Acne vulgaris in patients 12 years of age and older * Safety and effectiveness established in 2 clinical studies in patients 12 years of age and older * Safety and effectiveness in pediatric patients under the age of 12 have not been evaluated * New drug Antiacne, topical
10/14/2008 Zomig Nasal Spray zolmitriptan Migraine * Safety and effectiveness have not been established in pediatric patients less than18 years of age. * A single, multi-center, double-blind randomized placebo-controlled study failed to demonstrate efficacy in pediatric patients ages 12 -17 years for the acute treatment of migraine headaches * Adverse events similar to those observed in adults. Antimigraine
10/10/2008 Kogenate FS Antihemophilic Factor (Recombinant)* Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage See Package Insert for new information on biologics Hematology/Coagulation
10/08/2008 Zmax Oral Susp azithromycin Community-Acquired Pneumonia * Safety and effectiveness established in pediatric patients 6 months of age or older with community-acquired pneumonia. Use is supported by evidence from studies in adults with additional safety and PK data in pediatric patients * Safety and effectiveness in the treatment of pediatric patients < 6 months of age have not been established. * Safety and effectiveness in the treatment of pediatric patients with acute bacterial sinusitis have not been established * Information on dose, PK parameters, AE profile, lab abnormalities, and clinical studies * New indication Antibiotic
10/07/2008 Akten Ophthalmic gel 3.5% lidocaine hydrochloride Ocular surface anesthesia during ophthalmologic procedures * Safety and efficacy extrapolated from studies in adults and older pediatric patients using different ophthalmic formulations of lidocaine. * New dosage form Anesthetic, topical
09/29/2008 Videx EC didanosine HIV infection in >20 kg * Extended indication from adults to children weighing e20kg who can swallow capsules * Dosing is based on body weight not to exceed adult dose * Adverse events (AEs) are generally similar to those seen in adults * Information on dose, AEs, population PK analysis, lab abnormalities, and historical clinical studies Antiviral
09/19/2008 Nasacort AQ triamcinolone Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older * Expands pediatric use, or age range, to include patients 2 to 5 years of age * Dosing and administration information provided * Not recommended for children under 2 years of age * An effect on adrenal function in children 2 to 5 years of age cannot be ruled out * Pharmacokinetics were evaluated in children 2 to 5 years of age * Safety and efficacy were evaluated in one clinical study involving pediatric patients 2 to 5 years old * Studies in children >6 months and less than 2 years of age were not performed due to safety concerns since controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. Anti-inflammatory, topical
09/19/2008 Retrovir syrup, capsules and tablets zidovudine Used in combination with 18 other antiretroviral agents for the treatment of HIV-1 infection * Dosing and administration information provided to children 6 weeks to less than 18 years of age * Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies * New dosing regimen Antiviral
09/12/2008 GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant* Prevention of vulvar and vaginal cancer caused by HPV types 16 and 18 See Package Insert for new information on biologics Preventive Vaccine
09/03/2008 Valtrex valacyclovir Chickenpox; active or at risk for herpes virus infection * New indication for treatment of chickenpox in pediatric patients 2 to <18 years based on single-dose pharmacokinetic and multiple-dose safety data from an open-label trial with valacyclovir and supported by safety and extrapolated efficacy data from 3 randomized, double-blind, placebo-controlled trials evaluating oral acyclovir in pediatric patients with chickenpox * The efficacy and safety of valacyclovir have not been established in pediatric patients: o <12 years of age with cold sores o <18 years of age with genital herpes o <18 years of age with herpes zoster o <2 years of age with chickenpox, o for suppressive therapy following neonatal HSV infection * Adverse events similar to that of adults * Information on PK parameters, AEs, clinical studies, and preparation of an extemporaneous formulation Antiviral
08/28/2008 Zemuron rocuronium Adjunct to general anesthesia * Expanded pediatric indication to include 0-17 years. Previously approved in ages 3 months  14 years * Not recommended for rapid sequence intubation in pediatric patients * In clinical studies of rocuronium, onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique * The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium with general anesthetic agents can prolong the QTc interval * The time to maximum block for an intubating dose was shortest in infants and longest in neonates. The duration of clinical relaxation following an intubating dose is shortest in children > 2 years to 11 years and longest in infants * Additional information on dose, clinical studies, and PK/PD parameters Anesthetic agent
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder * Safety and effectiveness have not been established for patients less than 18 years of age * In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: o Hyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo o Hyperlipidemia  statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol o Weight gain  olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg Antipsychotic
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies * Extended indication from adults to children 3 months and older based upon evidence from adequate and well-controlled studies in adults and PK data in pediatric patients and additional data from pediatric studies * The efficacy and safety have not been adequately studied in infants < 3 months * The ability of caspofungin to penetrate the blood-brain barrier and to treat patients with meningitis and endocarditis is unknown * Dosing should be based on the patients body surface area. Maximum loading dose and daily maintenance dose should not exceed 70 mg * The safety profile in pediatrics is comparably to adults * Information on dose, Aes, PK parameters, clinical studies and infusion preparation instructions Antifungal
07/24/2008 Navstel Intraocular Irrigating Solution Sterile balanced salt ophthalmic solution with hypromellose, dextrose and glutathione Use as an intraocular irrigating solution during surgical procedures involving perfusion of the eye * Safety and efficacy have been demonstrated in pediatric patients * New active ingredient Ophthalmologic flush
07/01/2008 Flovent HFA fluticasone propionate Asthma in < 4 years * Flovent HFA should be administered by the orally inhaled route only in patients 4 years and older. * Clinical studies were conducted in children with asthma 6 months to less than 4 years * Information added to Pediatric Use Antiasthmatic
06/30/2008 Aciphex rabeprazole Gastroesophageal reflux in adolescent patients 12 years of age and above * Use in adolescent patients 12 years of age and older is supported by extrapolation of results from studies in adults and safety and PK studies performed in adolescent patients * Safety and effectiveness for GERD have not been established for pediatric patients <12 years of age * Safety and effectiveness for other uses have not been established in pediatric patients * Adverse events (Aes) similar to those seen in adults * Information on dose, Aes, clinical studies Antiulcerative
06/24/2008 KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine* Active immunization against diphtheria, tetanus, pertussis, & poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series when previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX and for the first three doses and INFANRIX for the fourth dose See Package Insert for new information on biologics Preventive Vaccine
06/24/2008 Viramune Tablets 200 mg Viramune Oral Suspension 10 mg/mL nevirapine Use in combination with other antiretroviral agents for the treatment of HIV-1 infection * Dosing information provided for children ages >15 days to <16 years old * Safety was evaluated in children 2 weeks and older in 5 clinical trials and important adverse events (all causality) include rash (21%), neutropenia (8.9%), anemia (7.3%) and hepatotoxicity (2.4%) * Safety, pharmacokinetics, and virologic and immunologic responses have been evaluated in HIV-infected pediatric patients age 3 months to 18 years * Safety and pharmacokinetics were evaluated in HIV-infected pediatric patients age 15 days to < 3 months * Efficacy was evaluated in one clinical study with children 3 months to 16 years of age * Post-marketing surveillance has shown anemia to be more commonly observed in children although development of anemia due to concomitant medication use cannot be ruled out * Potential drug interaction information is provided for children with respect to lopinavir/ritonavir * New dosing regimen Antiviral
06/23/2008 Aptivus tipranavir Co-administered with ritonavir for combination antiretroviral in patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor * Extended indication from adults to children 2 years and older * The risk-benefit has not been established in patients <2 years of age * Dosing is based on body weight or body surface area not to exceed adult dose * Aes are generally similar to those seen in adults however, rash was more frequent in pediatric patients than in adults; The frequency of rash through 48 weeks of treatment was 21%. Most rashes were mild and 5% were moderate. Overall 3% interrupted treatment due to rash * Information on dose, Aes, PK parameters, lab abnormalities, and clinical study Antiviral
06/20/2008 Kaletra lopinavir/ ritonavir Use in combination with other antiretroviral agents for HIV-1 infection * Extended indication from 6 months  12 years to 14 days  18 years * The safety, efficacy, and pharmacokinetic profiles in pediatric patients < 14 days have not been established * Dose should be calculated based on body weight or body surface area not to exceed adult dose * Because no data exists for dosage when administered with efavirenz, nevirapine, (fos)amprenavir, or nelfinavir, it is recommended that lopinavir/ ritonavir not be administered in combination with these drugs in patients < 6 months of age * Infants <6 months of age generally had lower lopinavir AUC12 than children 6 months  12 years of age * Information on dose, PK parameters, clinical studies, and AEs Antiviral
06/20/2008 Pentacel Diphtheria And Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine* Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b See Package Insert for new information on biologics Preventive Vaccine
06/05/2008 Zetia and Vytorin ezetimibe and ezetimibe/ simvastatin Heterozygous familial hypercholesterolemia as an adjunct to diet * The effects of ezetimibe co-administered with simvastatin compared to simvastatin monotherapy have been evaluated in adolescent boys and girls with heterozygous familial hypercholesterolemia (HeFH) Antilipemic
05/09/2008 OraVerse Injection 0.4 mg (0.235 mg/mL) phentolamine mesylate Reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor * Use in children less than 6 years of age or weighing less than 15 kg (33 lbs) is not recommended * Dosing information provided for children weighing 15 to 30 kg (66 lbs) * Safety and efficacy were established in 2 clinical trials in children 12 to 17 years old, one trial in children ages 6 to 11 years, as well as adult studies * Safety has been evaluated in pediatric patients under the age of 6 years but not efficacy * Pharmacokinetics have been evaluated in children weighing 15 kg or more * New indication Anesthetic, topical
05/08/2008 Desmopressin acetate Tablets, 0.1 mg and 0.2 mg desmopressin acetate Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE) * Efficacy in RCCT was evaluated in a single trial with children 3 to 18 years old * Three studies evaluated efficacy in children 5 to 17 years old with PNE; an additional study evaluated efficacy in adolescents 12 to 17 years old * Fluid intake should be adjusted downward in children to decrease the potential occurrence of water intoxication and hyponatremia * Dosing information provided for children 3 to 18 years old for RCCT * Dosing information provided for pediatric patients 6 years of age and older with PNE * Tablet dosage and administration information provided for children with central diabetes insipidus * Pharmacokinetics and pharmacodynamics were evaluated in children * New indications and dosing regimen Urology
05/05/2008 Argatroban argatroban Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis * Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients * Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages <6 months  16 years diagnosed with HIT or suspected HIT requiring an alternative to heparin anticoagulation showed clearance in pediatric patients was 50% lower compared to healthy adults and led to dose recommendations * Information on dose, AEs and PK Hematology/Coagulation
05/05/2008 Levaquin Tablets, 250 mg, 500 mg, and 750 mg Levaquin Oral Solution, 25 mg/mL Levaquin Injection and Levaquin Injection, 5 mg/mL levofloxacin levofloxacin in 5% dextrose injection Reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis (inhalational anthrax post-exposure) * New indication * Dosing information provided for children less than and greater than 50 kg * Efficacy is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit, and animal studies were used to evaluate survival; the product has not been tested in humans for the post-exposure prevention of inhalation anthrax * Safety in pediatric patients treated for more than 14 days has not been studied * Long-term safety data, including effects on cartilage, following administration in pediatric patients is limited * Due to possible side effects, use is not recommended for pediatric patients except in the prevention of anthrax after inhalational exposure * Pharmacokinetics were investigated in pediatric patients 6 months to 16 years old Antibiotic
04/30/2008 Cardiolite technetium tc99m sestamibi Medical imaging in Kawasaki disease * Safety and effectiveness have not been established in the pediatric population * No evidence of diagnostic efficacy or clinical utility of scan was found in 3 clinical studies of children and adolescents with Kawasaki disease * A study of 445 pediatric patients failed to demonstrate the predictive value of Cardiolite rest and stress myocardial perfusion imaging to define children with Kawasaki disease at risk of developing cardiac events 6 months after receiving Cardiolite; only 3cardiac events were observed. In all 3 cases, the scan was negative * Adverse events similar to that of adults * Information on dose, PK, and clinical studies Diagnostic aid
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older * Safety and effectiveness in children below the age of 12 years have not been established * Symptoms of antihistamine overdose in children may initially include agitation and restlessness followed by drowsiness * Efficacy and safety were evaluated in 3 clinical trials of 2 weeks duration in adult and adolescent patients, 12 years of age and older, with symptoms of SAR * Dosage and administration information provided for children 12 years and older * New indication, dosage form, dosing regimen, and route of administration Antihistamine
04/07/2008 Orencia abatacept Moderate to severe polyarticular juvenile idiopathic arthritis * Indicated for reducing signs and symptoms in pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) ages 6 years and older. * The safety and effectiveness in pediatric patients < 6 years of age and in pediatric patients for uses other than JIA have not been established * Abatacept was studied in 190 patients 6 - 17 years with polyarticular JIA. * AEs were generally similar to those seen in adults. Overall frequency of adverse events in the 4-month, lead-in, open-label period of the study was 70%; infections occurred at a frequency of 36%. A total of 6 serious adverse events were reported during the initial 4 months of treatment with abatacept. * Information on dosing, PK, immunogenicity, immunization needs, AEs, and clinical study * New indication Anti-inflammatory
04/03/2008 ROTARIX Rotavirus Vaccine, Live, Oral* Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) See Package Insert for new information on biologics Preventive Vaccine
03/31/2008 LancĂ´me UV Expert 40 La Roche-Posay Anthelios 40 Vichy Capital Soleil 40 avobenzone, ecamsule, octocrylene, titanium dioxide cream Sunscreen OTC * Effectiveness extrapolated from adult studies * Safety studies included pediatric patients 6 months of age and older * Age range based on standards established in over-the counter monograph for sunscreens * New active ingredient * Sunscreen
03/26/2008 Ventolin HFA albuterol Treatment of symptoms of bronchospasm associated with obstructive airway disease * Safety and effectiveness of albuterol administered with or without a spacer device in children < 4 years of age has not been demonstrated * 3 randomized, double-blind, placebo-controlled studies in 250 children < 4 years, in which efficacy was not demonstrated, suggest that either the optimal dose has not been defined in this age-group or the drug is not effective in this age-group * Information on clinical studies Antiasthmatic
03/25/2008 Reyataz atazanavir HIV in 6 years and older * Extended indication from adults to children 6 years and older * The safety, activity, and pharmacokinetic profiles in pediatric patients ages 3 months to < 6 years have not been established. Atazanavir should not be administered to pediatric patients below the age of 3 months due to the risk of kernicterus * Dosing is based on body weight or body surface area not to exceed adult dose * Adverse events (AEs) are generally similar to those seen in adults * Information on dose, AEs, PK parameters, lab abnormalities, and clinical study Antiviral

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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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