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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
09/18/2009 AndroGel testosterone Use in adolescent boys with delayed puberty * New safety information added to labeling including a Boxed Warning, and revisions to the Warnings and Precautions, Adverse Reactions, and Patient Counseling sections on the risk of virilization from secondary exposure of children to testosterone due to drug transfer from unwashed or uncovered application skin sites of adult males using testosterone gel products * Safety and efficacy have not been established in males < 18 years Androgen-anabolic steroid
09/08/2009 Bepreve Ophthalmic Solution bepotastine besilate Ocular itching associated with allergic conjunctivitis * Efficacy in pediatric patients 2 years to < 10 years based on clinical trials conducted in pediatric patients > 10 years and from adults * Safety and efficacy have not been established in pediatric patients < 2 years * New drug Antihistamine, topical
09/02/2009 Intuniv guanfacine ADHD * Efficacy established in 2 controlled clinical trials in children 6-17 years * Safety and efficacy in pediatric patients< 6 years have not been established * In clinical trials, there were dose and exposure-related risks for adverse events (AEs) including hypotension, bradycardia, and sedative events. Somnolence and sedation were reported in 38% on guanfacine vs. 12% on placebo in children and adolescents with ADHD, especially during initial use * Information on dosing, clinical trials, and AEs * New dosage form Non-stimulant ADHD treatment
08/31/2009 Astepro Nasal Spray azelastine hydrochloride Seasonal and perennial allergic rhinitis in patients 12 years of age and older. * Safety and efficacy for the treatment of seasonal and perennial allergic rhinitis were evaluated in 7 controlled clinical trials in patients 12 years and older * Information on clinical trials, dosing, and adverse events (AEs) * New indication (PAR) and dosing regimen Antihistamine
08/28/2009 Valcyte valganciclovir Prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients e 4 months of age * Use in pediatric patients e 4 months is based on efficacy data from a study in adults and PK, safety, and efficacy data from an open-label trial in pediatric solid organ transplant recipients at risk for developing CMV disease * The efficacy and safety have not been established in children for: 1. Prevention of CMV disease in liver transplant patients 2. Prevention of CMV disease in solid organ transplants other than those indicated 3. Prevention of CMV disease in pediatric solid organ transplant patients < 4 months of age 4. Treatment of congenital CMV disease * Adverse events (AEs) similar to adult patients, however, certain Aes including upper respiratory tract infection, pyrexia, nasopharyngitis, anemia, and neutropenia were reported more frequently in pediatric patients * Information on dosing, PK, and clinical study * New dosage form Antiviral
08/27/2009 Zenpep pancrelipase Exocrine pancreatic insufficiency due to cystic fibrosis * Safety and efficacy assessed in 2 studies which included pediatric patients ages 1-17 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 with the same active ingredient. * High doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures 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 studies * Not interchangeable with other pancrelipase products * New drug Pancreatic enzyme
08/21/2009 Xyzal levocetirizine dihydrochloride Seasonal allergic rhinitis (SAR) in children 2 years of age and older; perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU) for children 6 months of age and older * Expanded age range for CIU down to 6 months; previously approved for use in 12 years and older * Expanded age range for PAR down to 6 months; previously approved for use in 6 years and older * Expanded age range for SAR down to 2 years; previously approved for use in 6 years and older * Pediatric use is supported by evidence from studies in adults with additional safety and PK data in pediatrics * Patient population altered Antihistamine
08/19/2009 HIBERIX Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) * Active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b See Package Insert for new information on biologics Preventive Vaccine
07/31/2009 Xerese acyclovir/ hydrocortisone Recurrent herpes labialis (cold sores) in 12 years of age and older * Use in adolescents e12 years is supported by evidence from studies in adults with additional safety data in adolescents e12 years * Safety and effectiveness in pediatric patients < 12 years have not been established * Information on clinical studies, and adverse events * New drug Antiviral, topical
07/23/2009 Actonel risedronate Osteogenesis imperfecta * Safety and effectiveness have not been established in pediatric patients * In a 1 year double-blind, placebo controlled study of pediatric patients with osteogenesis imperfecta (OI), treatment with risedronate did not result in a reduction in the risk of fracture * Adverse events similar to those observed in adults except for an increased incidence in vomiting * Information on clinical study Bone density
07/10/2009 Plan B One Step levonorgestrel Emergency contraception - OTC in women 17 years and older; RX for women younger than age 17 years * New single dose 1.5 mg tablet * New dosage regimen Contaceptive
06/18/2009 Nexium esomeprazole Short-term treatment of GERD * Effectiveness was not demonstrated in a randomized, placebo-controlled study in neonates to < 1 year * Information on clinical study, PK/PD parameters Antiulcerative
05/29/2009 Lamictal XR lamotrigine Adjunctive therapy for partial onset seizures in patients e13 years of age * Extended release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients e13 years * Safety and effectiveness of extended release tablets for any use in patients below the age of 13 have not been established * Information on adverse event profile, and clinical studies * New dosage form Anticonvulsant
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

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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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