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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 500
n = 453 with New Pediatric Studies; n = 47 with No New Pediatric Studies
BPCA only = 157; BPCA + PREA = 66; PREA only = 228; Rule = 48; None = 1

Pediatric Labeling Changes as of September 30, 2013

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:  500
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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
03/24/2008 Depakote ER Depakote Sprinkles divalproex disodium Pediatric Bipolar Disorder; Prophylaxis of Migraine * Efficacy was not established in a double-blind, placebo controlled study of patients 10-17 years conducted to evaluate efficacy in the treatment of pediatric bipolar disorder * Efficacy was not established in a double-blind, placebo-controlled study of patients 12  17 years conducted to evaluate the efficacy in the prophylaxis of migraine * The safety and tolerability was similar to adults in 5 long-term safety studies * Additional information on clinical studies, AE profile in Depakote ER labeling Anticonvulsant; Mood Stablizer
03/20/2008 Prilosec omeprazole Maintenance healing of erosive esophagitis * Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial * Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. * Safety and effectiveness in children less than 1 year of age have not been established * Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. * New dosage form Antiulcerative
03/20/2008 Zometa zoledronic acid Severe osteogenesis imperfecta * Zoledronic acid is not indicated for use in children * Safety and effectiveness was studied in 152 pediatric patients with severe osteogenesis imperfecta aged 1 - 17 years. At one year, increases in BMD were observed in the zoledronic acid treatment group but the changes did not necessarily correlate with the risk for fracture or the incidence or severity of chronic bone pain * Information on PK, clinical study, and AE profile Bone density
03/19/2008 ARTISS Fibrin Sealant (Human)* To adhere autologous skin grafts to surgically prepared wound beds resulting from burns See Package Insert for new information on biologics Wound healing
03/14/2008 NovoLog insulin aspart [rDNA origin] injection Insulin analog indicated to improve glycemic control * Efficacy was demonstrated in a clinical study with pediatric patients ages 4 to 18 years using an external insulin pump * New dosing regimen Antidiabetic
03/12/2008 DAPTACEL Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed* Active immunization as a booster dose against diphtheria, tetanus & pertussis See Package Insert for new information on biologics Preventive Vaccine
02/27/2008 Abilify aripiprazole Bipolar I Disorder * Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years * The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated * The recommended target dose in Bipolar Disorder is 10 mg/day. * In the study of pediatric patients 10  17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion * Information on dose, AEs, clinical studies Antipsychotic
02/27/2008 Nexium esomeprazole Short-term treatment of GERD * Expanded age range to include pediatric patients 1-11 years. Previously approved in 12-17 years * Use in pediatric patients 1 to 17 years of age is supported by extrapolation from studies in adults, and safety and PK studies performed in pediatric and adolescent patients * Safety and effectiveness in pediatric patients <1 year of age have not been established * Safety and effectiveness for other pediatric uses have not been established * Information on dose, treatment related adverse events (AEs), clinical study * New formulation Antiulcerative
02/21/2008 Humira adalimumab Treatment of juvenile idiopathic arthritis * Indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA)in patients 4 years of age and older * Has not been studied in children <4 years of age; there are limited data on treatment in children with weight <15 kg * Safety and efficacy in pediatric patients for uses other than JIA have not been established * Adalimumab was studied in 171 patients 4 - 17 years with polyarticular JIA. * AEs were generally similar to those seen in adults. 45% of children experienced an infection while receiving adalimumab with or without concomitant MTX in the first 16 weeks of treatment. Serious infections were observed in 4% of patients within approximately 2 years of initiation of treatment * Information on dose, AEs, lab abnormalities, PK parameters, immunogenicity, immunization needs and clinical study * New indication Anti-inflammatory
02/01/2008 Asmanex Twisthaler 110mcg inhalation powder mometasone furoate Maintenance treatment of asthma as prophylactic therapy in children 4 years of age and older * Not indicated for relief of acute bronchospasm or in children less than 4 years of age * Clinical studies, including 52 week safety trial conducted in children 4  11 years of age * Pediatric dosing information provided * Child may not get the most benefit for 1 to 2 weeks or longer after starting treatment * New dosage form Antiasthmatic
01/31/2008 Inspra eplerenone Hypertension * Effectiveness was not established in a study of 304 hypertensive pediatric patients 4 - 17 years; eplerenone, at doses up to 100 mg/ day, did not lower blood pressure effectively * Therefore, it has not been studied in hypertensive patients <4 years old * Eplerenone has not been studied in hypertensive patients < 4 years or in pediatric patients with heart failure * Adverse events similar to that of adults Antihypertensive
01/28/2008 Xyzal 0.5 mg/mL Oral Solution levocetirizine dihydrochloride Relief of symptoms associated with seasonal and perennial allergic rhinitis (SAR and PAR) and treatment of uncomplicated skin manifestations of chronic idiopathic urticaria (CIU) * Dosing information provided * Studies waived in children less than 6 months of age with PAR and CIU * Waived in children less than 2 years of age with SAR * New dosage form pediatric Antihistamine
01/23/2008 Moxatag amoxicillin Use for tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes patients 12 years of age and older * Safety and effectiveness in pediatric patients younger than 12 years have not been established * One clinical study evaluated safety and effectiveness in pediatric patients 12 years of age and older with no significant differences in treatment response or adverse reactions between adults and children * A prospective study of 51 children suggested that overdosages of less than 250 mg/kg are not associated with significant clinical symptoms and do not require gastric emptying * Waiver of studies in children ages 0 to less than two years because too few children have the disease * New dosage form Antibiotic
01/17/2008 TamiFlu oseltamivir Safety information resulting from studies that established treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older * Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. * These events have been reported in patients receiving oseltamivir, primarily among pediatric patients, appear to be uncommon, and often had an abrupt onset and rapid resolution * If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient Antiviral
01/10/2008 Alvesco Inhalation Aerosol, 80 mcg & 160 mcg ciclesonide Treatment of asthma in patients 12 years of age and older. * Not indicated for children under the age of 12 years * Five clinical studies evaluated safety in children 12 years of age and older * Safety and effectiveness have not been established in children under 12 years of age * Waiver of studies in children 0 to less than 6 months of age due to too few patients with the disease * New dosage form Antiasthmatic
01/02/2008 EVICEL Fibrin Sealant (Human)* Adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical See Package Insert for new information on biologics Coagulant
12/27/2007 AndroGel testosterone Use in adolescent boys with delayed puberty * Safety and efficacy in males < 18 years old have not been established * Improper use may result in acceleration of bone age and premature closure of epiphyses Androgen-anabolic steroid
12/27/2007 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
12/19/2007 Hepsera adefovir dipivoxil Chronic hepatitis B virus infection * Extended indication from adults to pediatric patients 12 years and older * Not recommended for children <12 years of age. Efficacy was not significantly different from placebo in a clinical study in children <12 years * Safety e12  < 18 years was similar to that observed in adults * Information on PK, AEs, clinical study, clinical resistance Antiviral
12/12/2007 Derma-Smoothe/FS Topical Oil fluocinolone Treatment of atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks * Extended age range down to 3 months * Effectiveness and safety are not established in children less than 3 months old * Safety was evaluated in two pediatric clinical studies (including facial use) * Pediatric dosing and administration information provided * Studies waived in children under 3 months of age due to safety concerns of adrenal suppression * New indication Anti-inflammatory, topical
11/29/2007 Diovan valsartan Hypertension * Labeling for 6-16 years of age * Not recommended for pediatric patients less than 6 years due to safety findings possibly related to treatment or with glomerular filtration rate < 30mL/min/1.73m2 * Information on dose, clinical studies in 1-16 years and pharmacokinetics * No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients * Information on preparation of a suspension Antihypertensive
11/29/2007 Triesence 40mg/mL triamcinolone acetonide injectable suspension Visualization during vitrectomy * Efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations * Adverse effects of corticosteroids in pediatric patients are similar to those in adults * New indication Anti-inflammatory, topical
11/21/2007 Omnaris Nasal Spray ciclesonide Treatment of seasonal allergic rhinitis (SAR) in patients 6 through less than 12 years of age * Indication extended down to 6 years of age * Pediatric dosing information provided * Two clinical studies evaluated safety in children 6 to 11 years of age and the overall incidence of adverse events was comparable to those treated with placebo * Efficacy in children 2 to 5 years of age was not established in clinical trials conducted in this age group. * Waiver of studies in children ages 0 to less than 2 years of age for SAR because of local and systemic safety concerns as well as lack of disease and/or diagnosis difficulties in children * New indication Antiasthmatic; antiallergy
11/09/2007 Kaletra Oral Solution, 80 mg/20 mg & Kaletra (1opinavir/ritonavir) Tablets, 200 mg/50 mg lopinavir/ ritonavir HIV -1 protease inibitor indicated in combination with other antiretroviral agents for the treatment of HIV -1 infection. * Dosing and administration information provided for children * Use of a lower strength tablet in a twice daily dosing regimen for pediatric patients weighing greater than 15 kg * New dosing regimen Antiviral
10/30/2007 Combigan 0.2%/0.5% ophthalmic solution brimonidine tartrate/timolol maleate Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension * Safety and effectiveness supported by evidence from clinical studies in adults with additional data from a study in children with glaucoma ages 2  7 years old * Not recommended for use in children under the age of 2 years due to safety concerns based on reports of apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence in infants * Safety and effectiveness have not been studied in children below the age of two years * New active ingredient Ophthalmologic hypotensive
10/29/2007 Abilify aripiprazole Schizophrenia * Extended schizophrenia indication from adults to adolescents 1317 years * Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established * Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated * In 6-week placebo controlled efficacy trial in patients 13  17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day * Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship * Information on dose, AEs, clinical studies Antipsychotic
09/28/2007 Lamisil Oral Granules terbinafine Tinea capitis * New indication in 4 years and older * Two randomized safety and efficacy trials were conducted in patients 4 to 12 years old with tinea capitis. Terbinafine was dosed on a mg/kg basis and treated for 6 weeks * Although no hepatotoxicity was seen during trials, pre-treatment serum transaminases tests are advised. * The most common adverse events observed in the trials were nasopharyngitis, headache, pyrexia, cough, vomiting, and upper respiratory tract infection * New 125 mg and 187.5 mg oral granule formulations developed; take with food * Information on dose, PK parameters, AE profile, and instructions for use Antifungal, topical
09/20/2007 Norditropin Cartridges somatropin (rDNA origin) Treatment of short stature in children with Turner syndrome * Safety and effectiveness based on studies in pediatric patients * New Warning: Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions * Information on recommended dosing, adverse events (AEs) and clinical studies * New indication Growth hormone
09/11/2007 Levaquin levofloxacin Community-acquired pneumonia * Levofloxacin is not indicated for pediatric patients < 18 years of age * In a prospective, long-term, surveillance study, levofloxacin treated children had a significantly higher incidence of musculoskeletal (MS) disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) compared to non-fluoroquinolone-treated children * Information on clinical studies, AE profile Antibiotic
08/22/2007 Risperdal risperidone Schizophrenia; short-term treatment of acute manic or mixed Episodes associated with Bipolar I Disorder * Extended schizophrenia indication from adults to adolescents 1317 years; extended bipolar mania indication from adults to children and adolescents 10-17 years * Safety and effectiveness in children < 13 years of age with schizophrenia have not been established; safety and effectiveness in children < 10 years of age with bipolar mania have not been established * No additional benefit was seen above 3 mg/day in schizophrenia studies and 2.5 mg/day in the Bipolar mania study; higher doses were associated with more adverse events. Doses higher than 6 mg/day have not been studied. * Information on dose, clinical studies, AE profile Antipsychotic
08/17/2007 Provigil modafinil Narcolepsy * Modafinil is not approved for use in pediatric patients for any indication * Safety and effectiveness were not demonstrated in a controlled 6-week study in 165 pediatric patients 5-17 years with narcolepsy * Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil * In the controlled and open-label clinical studies, treatment emergent adverse events of the psychiatric and nervous system included Tourettes syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations and suicidal ideation * Information on safety, AEs and clinical study CNS Stimulant
08/16/2007 Zingo lidocaine Topical local analgesia prior to venipuncture or peripheral intravenous cannulation in children 3-18 years of age *Su mmary is pending Anesthetic, topical
07/18/2007 Toprol XL metoprolol Hypertension * A study in 144 pediatric hypertensive pediatric patients aged 6 - 16 years did not meet its primary endpoint. However, some study endpoints demonstrated effectiveness * Adverse event profile similar to adults * Safety and effectiveness have not been established in patients < 6 years of age * Information on PK parameters, clinical studies, and dose Antihypertensive
06/14/2007 Lexiva Oral Suspension fosamprenavir Treatment of HIV infection in patients 2-18 years of age * Effectiveness and safety were established in two clinical studies of pediatric patients 2-18 years of age * Adverse event profile is similar to that of adults with the exception of vomiting, which, regardless of causality, occurred more frequently among pediatric patients * Dosing information provided * Studies waived in children 0-1 month of age and deferred in children 1 month - 2 years of age * New dosage form Antiviral
06/12/2007 Extina Foam, 2% ketoconazole Topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older * Effectiveness and safety were established in a clinical study that included 44 patients from 12-17 years of age * Studies waived in children 0-12 years of age * New dosage form Antifungal, topical
06/08/2007 Betoptic S betaxolol Elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension * Extended indication from adults to pediatric patients * The adverse reaction profile was comparable to that seen in adults Ophthalmologic hypotensive
06/08/2007 Timolol GFS timolol Elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension * Extended indication from adults to pediatric patients * The adverse reaction profile was comparable to that seen in adults Ophthalmologic hypotensive

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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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