|
12/19/2012
|
Advair HFA
|
fluticasone/ salmeterol
|
Treatment of asthma
|
*Safety and effectiveness in children < 12 years have not been established.* Information on clinical trials, adverse reactions, and pharmacokinetics/ pharmacodynamics, * Postmarketing study
|
Antiasthmatic
|
|
12/14/2012
|
Fluarix Quadrivalent
|
Influenza Virus Vaccine*
|
Include a quadrivalent influenza virus vaccine formulation (Fluarix® Quadrivalent)
|
See Package Insert for new information on biologics
|
Vaccine
|
|
11/30/2012
|
Invirase
|
saquinavir
|
Treatment of HIV infection in combination with ritonavir
|
*The safety and activity of saquinavir have been evaluated in 68 pediatric patients 4 months -< 16 years treated with Invirase boosted with either ritonavir or with lopinavir/ritonavir in 2 clinical trials. * Steady state saquinavir exposures observed in pediatric trials were substantially higher than historical data in adults where dose- and exposure-dependent QTc and PR prolongation were observed. Pediatric dose recommendations that are both reliably effective and below thresholds of concern with respect to QT and PR prolongation could not be determined. * Information on clinical studies, and pharmacokinetics
|
Antiviral
|
|
11/08/2012
|
VIRAMUNE XR
|
nevirapine
|
Treatment of HIV-1 infection
|
* Approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in children 6 - < 18 years. Use in pediatric patients 6 - < 18 years is based on pharmacokinetic, safety, and antiviral activity data from an open-label trial and supported by previous demonstration of efficacy in adults. * Not recommended for children < 6 years since clinical trial did not provide sufficient pharmacokinetic data for children 3 - < 6 years to support the use in this age group. Furthermore, not recommended for children < 3 years because they are not able to swallow tablets. * Viramune XR tablets must be swallowed whole and must not be chewed, crushed, or divided. * Children should be assessed for their ability to swallow tablets before prescribing * No recommendations can be made regarding substitution of four VIRAMUNE XR 100 mg tablets for one VIRAMUNE XR 400 mg tablet * Pediatric patients may be dosed using Viramune XR 400 mg or 100 mg tablets. Viramune XR is dosed based on a patients body surface area (BSA). All pediatric patients must initiate therapy with immediate-release Viramune at a dose not to exceed 200 mg per day, administered once daily for the first 14 days because it has been demonstrated to reduce the frequency of rash. This lead-in period is not required if the patient is already on a regimen of twice daily immediate-release formulation * Adverse reactions were similar to those observed in adults. In pediatric patients the incidence of Grade 2 or higher drug-related rash was 1%Information on recommended dosing based on BSA, pharmacokinetics, adverse reactions, and clinical trial * Postmarketing study
|
Antiviral
|
|
10/22/2012
|
Fycompa
|
perampanel
|
Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy
|
*The safety and efficacy was established by 3 double blind, placebo-controlled studies which included 72 pediatric patients 12 - 16 years old exposed to perampanel *The safety and effectiveness in pediatric patients <12 years old have not been established *Most common adverse reactions in adult and pediatric patients include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, gait disturbance, and balance disorder *Information on clinical trials, dosing, adverse reactions, and pharmacokinetics * New drug
|
Anticonvulsant
|
|
10/19/2012
|
Oxtellar XR
|
oxcarbazepine
|
Adjunctive therapy of partial seizures
|
*Safety and effectiveness in pediatric patients ages 6 - 16 years with partial onset seizures is supported by an adequate and well-controlled short term safety and efficacy study in adults that included pharmacokinetic sampling, a pharmacokinetic study in pediatric patients ages 4 - 16 years, and safety and efficacy studies with the immediate-release formulation in adults and pediatric patients * Oxtellar XR is not approved for pediatric patients < 6 years because the size of the tablets are inappropriate for younger children, and has not been studied in patients < 4 years * Information on dosing, adverse reactions, and pharmacokinetics * New dosage form
|
Anticonvulsant
|
|
10/18/2012
|
Cymbalta
|
duloxetine hydrochloride
|
Treatment for Major Depressive Disorder (MDD)
|
*Efficacy was not demonstrated in two 10-week, placebo-controlled trials with 800 pediatric patients with MDD, age 7-17 *Duloxetine has not been studied in pediatric patients less than 7 years *Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. Pediatric patients treated with duloxetine in MDD clinical trials experienced a 0.2 kg mean decrease in weight at 10-weeks, compared with a mean weight gain of approximately 0.6 kg in placebo-treated patients. The proportion of patients who experienced a clinically significant decrease in weight (>3.5%) was greater in the duloxetine group than in the placebo group (11% and 6%, respectively). Subsequently, over the six-month uncontrolled extension period, most duloxetine treated patients trended toward recovery to their expected baseline weight. Perform regular monitoring of weight and growth in children and adolescents treated with an SNRI such as duloxetine *In the 2 pediatric MDD studies, the safety findings were consistent with the known safety and tolerability profile for duloxetine *Information on clinical trial, pharmacokinetics, and juvenile animal study
|
Antidepressant
|
|
10/10/2012
|
Lunesta
|
eszopiclone
|
Attention-Deficit Hyperactivity Disorder associated insomnia
|
*Safety and effectiveness have not been established in pediatric patients*Lunesta failed to demonstrate efficacy in a 12-week controlled study of 483 pediatric patients 6-17 years with insomnia associated with ADHD *Psychiatric and nervous system disorders comprised the most frequent treatment emergent adverse reactions observed with Lunesta versus placebo and included dysgeusia (9% vs. 1%), dizziness (6% vs. 2%), hallucinations (2% vs. 0%) and suicidal ideation (0.3% vs. 0%) * Information on dose, adverse reactions clinical trial and juvenile animal studies
|
Hypnotic
|
|
09/27/2012
|
QUILLIVANT XR
|
methylphenidate hydrochloride
|
Treatment of Attention Deficit Hyperactivity Disorder
|
*Safety and effectiveness have been established in pediatric patients ages 6 - 17 years *Use in pediatric patients 6 - 12 years of age is supported by adequate and well-controlled studies. Use in 12 - 17 year olds is supported by the adequate and well-controlled studies of Quillivant XR in younger pediatric patients and additional pharmacokinetic data in adolescents, with safety information from other methylphenidate products *The long-term efficacy of methylphenidate in pediatric patients has not been established *Safety and efficacy in pediatric patients below the age of 6 years have not been established *Growth should be monitored during treatment with stimulants, including Quillivant XR. Children who are not growing or gaining weight as expected may need to have their treatment interrupted *Information on adverse reactions, pharmacokinetics and clinical tria l*New dosage form
|
CNS Stimulant
|
|
09/21/2012
|
Venofer
|
iron sucrose
|
Treatment of iron deficiency anemia in patients with chronic kidney disease (CKD)
|
*Expanded the indication from adults to pediatric patients 2 years and older* Safety and effectiveness for iron maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied *Safety and effectiveness for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established *Venofer has not been studied in patients < 2 years *The mean Cmax and AUC values were 1.42- and 1.67-fold higher than dose adjusted adult Cmax and AUC values *The most common treatment-emergent adverse reactions were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%) *Information on dosing, adverse reactions, pharmacokinetics, and clinical trial * Postmarketing study
|
Iron Replacement
|
|
08/30/2012
|
Revatio
|
sildenafil
|
Treatment of pulmonary arterial hypertension
|
*Use of Revatio, particularly chronic use, is not recommended in children *In a double-blind, placebo-controlled, dose-ranging study, 234 pediatric patients with PAH 1 - 17 years were randomized based on body weight to three dose levels of Revatio, or placebo, for 16 weeks. No patients died during the 16-week study *In a long-term trial, an increase in mortality with increasing dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH * Information on safety, and clinical trials
|
Peripheral Vasodilator
|
|
08/21/2012
|
Veramyst
|
fluticasone furoate
|
Postmarketing study
|
*Information on a one-year linear growth study in children * Postmarketing study
|
Anti-inflammatory, topical
|
|
08/16/2012
|
Viread
|
tenofovir disoproxil fumarate
|
Treatment of chronic hepatitis B
|
*Expanded the indication from adults to pediatric patients 12 - < 18 years of age, weighing at least 35k*Safety and efficacy in pediatric patients with chronic hepatitis B < 12 years old or weighing < 35 kg have not been established *In a clinical trial in pediatric patients 12 - <18 years, the mean rate of bone mineral density gain was less in Viread-treated patients compared to placebo* Information on dosing, adverse reactions, and clinical trial *Postmarketing study
|
Antiviral
|
|
08/02/2012
|
Risperdal
|
risperidone
|
Postmarketing study
|
* Information on postmarketing clinical study of a lower than recommended dose for irritability associated with autistic patients in patients 5 to 17 years * Postmarketing study
|
Antipsychotic
|
|
06/26/2012
|
Treanda
|
bendamustine hydrochloride
|
Relapsed or refractory acute leukemia
|
*Effectiveness in pediatric patients has not been established * Treanda was evaluated in a Phase 1/2 trial in pediatric patients with leukemia *The safety profile in pediatric patients was consistent with that seen in adults, and no new safety signals were identified *Information on dosing, clinical trials and PK parameters
|
Antineoplastic
|
|
06/14/2012
|
MENHIBRIX
|
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine*
|
Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b
|
See Package Insert for new information on biologics
|
Preventive Vaccine
|
|
05/30/2012
|
Torisel
|
temsirolimus
|
Advanced recurrent/refractory solid tumors
|
* Effectiveness in pediatric patients has not been established * Torisel was studied in 59 patients 1 - 17 years and 12 patients 18 to 21 years in a phase 1-2 safety and exploratory pharmacodynamic study * Adverse reactions were similar to those observedd in adults * Information on dosing, clinical trials and PK parameters
|
Antineoplastic
|
|
05/17/2012
|
Pertzye
|
pancrelipase
|
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
|
* Safety and efficacy assessed in a clinical trial that included 10 patients 8 - 17 years *Safety and efficacy of pancreatic enzyme products with different formulations of the same active ingredient for use in children have been described in medical literature and through clinical experience * Use in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended *High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age *Capsule should be swallowed whole. Capsule and contents should not be crushed or chewed *For patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce and swallowed immediately * Not interchangeable with other pancrelipase products *New drug
|
Pancreatic enzyme
|
|
05/12/2012
|
Voluven
|
6% Hydroxyethyl Starch 130/0.4 In 0.9% Sodium Chloride Injection*
|
Plasma volume substitute for treatment and prophylaxis of hypovolemia
|
See Package Insert for new information on biologics
|
Coagulant
|
|
05/01/2012
|
Dymista
|
azelastine hydrochloride and fluticasone proprionate
|
Relief of symptoms of seasonal allergic rhinitis
|
*Safety and effectiveness have been established in 3 clinical trials in patients 12 years and older *Safety and effectiveness in pediatric patients < 12 years have not been established *Intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including Dymista, should be monitored routinely *Information on dosing, adverse reactions, and clinical trials *New drug
|
Antiasthmatic;antiallergy
|
|
04/27/2012
|
Lexiva
|
fosamprenavir
|
Treatment of HIV-1 infection
|
* Expanded indication to include pediatric patients at least 4 weeks - <2 years; previously approved for use in 2 18 years *The PK, safety, tolerability, and efficacy in pediatric patients < 4 weeks have not been established *Dosing of Lexiva plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients <6 months of age; data do not support twice-daily dosing of Lexiva without ritonavir in pediatric patients <2 years *Weight-adjusted apparent clearance was higher in children < 4 years, suggesting that younger children require higher mg per kg dosing of Lexiva *Vomiting and neutropenia were more frequent in pediatrics than in adults. Other adverse reactions were similar to adults * Information on dosing, clinical trials, PK and adverse reactions *New dosage regimen for patients at least 4 weeks - < 6 years; Postmarketing study
|
Antiviral
|
|
04/27/2012
|
Levaquin
|
levofloxacin
|
Treatment and prophylaxis of plague due to Yersinia pestis
|
* Approved for the treatment and prophylaxis of plague due to Yersinia pestis in patients 6 months and older *Efficacy studies could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. Approval of this indication was based on an efficacy study conducted in animals *Safety and effectiveness in pediatric patients < 6 months have not been established *Information on animal study *New indication
|
Antibiotic
|
|
03/26/2012
|
Singulair Oral Granules, Tablets, and Chewable Tablets
|
montelukast
|
Prevention of exercise-induced bronchoconstriction
|
* Expanded indication to include pediatric patients from 6 - 14 years; previously approved for use in 15 years and older *Efficacy for prevention of EIB in patients < 6 years of age has not been established * Information on clinical trial, and dosing * Postmarketing study
|
Antiasthmatic; antiallergy
|
|
03/26/2012
|
Intelence
|
etravirine
|
Treatment of HIV-1 infection in treatment-experienced patients in combination with other antiretroviral agents
|
* Expanded the indication from adults to pediatric patients 6 years and older * Safety and efficacy have not been established in children < 6 years or in treatment naive adult or pediatric patients *Adverse reactions were similar to those observed in adults except for rash which was observed more frequently in pediatric patients (15%) compared to adults (10%)*Intelence tablet(s) should be swallowed whole. Patients who are unable to swallow the Intelence tablet(s) whole may disperse the tablet(s) in a glass of water *Information on dosing in pediatric patients 6 - <18 years and weighing at least 16 kg, dispersing tablet in water, adverse reactions, and clinical trial *Postmarketing study
|
Antiviral
|
|
03/23/2012
|
QNASL
|
beclomethasone dipropionate
|
Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis
|
"Safety and effectiveness in children 12 years and older have been established "Safety and effectiveness in <12 years have not been established "Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving QNASL Nasal Aerosol "The potential for QNASL Nasal Aerosol to cause reduction in growth velocity in susceptible patients or when given at higher than recommended dosages cannot be ruled out "Information on safety, adverse events and clinical trials "New dosage form
|
Anti-inflammatory, topical
|
|
03/14/2012
|
Natazia
|
estradiol valerate and estradiol valerate/dienogest
|
Treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception
|
"Safety and efficacy have been established in women of reproductive age. Safety and efficacy for post pubertal adolescents < 18 are expected to be the same as for 18 years and older "Use of this product before menarche is not indicated "New indication
|
Contraceptive
|
|
03/01/2012
|
Ultresa
|
pancrelipase
|
Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions
|
"Safety and efficacy assessed in 2 studies that included patients 7--17 years "Safety and efficacy of pancreatic enzyme products with different formulations of the same active ingredient for use in children have been described in medical literature and through clinical experience "High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age " Adverse reactions similar to adults "Use in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended "Children > 12 months and < 4 years, weighing < 14 kg and children e 4 years, weighing < 28 kg should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children "Capsule should be swallowed whole. Capsule and contents should not be crushed or chewed. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce and swallowed immediately "Information on dosing and clinical studies "Not interchangeable with other pancrelipase products "New drug
|
Pancreatic enzyme
|
|
02/29/2012
|
FluMist Quadrivalent
|
Influenza Vaccine Live, Intranasal*
|
Active immunization for the prevention of disease caused by influenza
|
See Package Insert for new information on biologics
|
Vaccine
|
|
02/09/2012
|
Famvir
|
famciclovir
|
Recurrent herpes labialis
|
"Efficacy has not been established in pediatric patients for the treatment of recurrent herpes labialis "Information on an open label PK, safety and efficacy study in children 12 to <18 years with recurrent herpes labialis added to Pediatric Use subsection of labeling"Postmarketing study
|
Antiviral
|
|
02/07/2012
|
Sklice
|
ivermectin
|
Topical treatment of head lice infestations
|
"Safety and effectiveness in children 6 months and older have been established "Safety has not been established in pediatric patients < 6 months. Sklice Lotion is not recommended in pediatric patients <6 months of age because of the potential increased systemic absorption and risk of ivermectin toxicity" Information on dosage and administration, adverse reactions, pharmacokinetics and clinical trials"New drug
|
Pediculocide, topical
|
|
01/25/2012
|
TISSEEL
|
Fibrin Sealant*
|
Hemostasis: An adjunct to hemostasis in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: An adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies
|
See Package Insert for new information on biologics
|
Wound healing
|
|
01/18/2012
|
Viread
|
tenofovir disoproxil fumarate
|
Treatment of HIV infection in combination with other antiretroviral agents
|
*Viread tablets: Expanded the indication from adults to pediatric patients 2 - < 12 years, weighing greater than or equal to 17 kg, who can swallow an intact tablet; tablet previously approved for use in 12 years and older * Viread Oral Powder: Expanded the indication from adults to pediatric patients 2 years of age and older * Safety and effectiveness in patients <2 years have not been established *Viread oral powder should be mixed in a container of soft food not requiring chewing (e.g., applesauce, baby food, yogurt) and ingested immediately to avoid a bitter taste *Adverse reactions were similar to those observed in adults *Postmarketing study, new dosage form
|
Antiviral
|
|
12/21/2011
|
Isentress
|
raltegravir
|
In combination with other antiretroviral agents for the treatment of HIV-1 infection
|
*Isentress Chewable tablets: Expanded indication from adults to pediatric patients 2 - < 12 years and weighing at least 10kg *Isentress Tablets: Expanded indication from adults to pediatric patients 6-18 years *Safety and effectiveness in patients <2 years have not been established*Because the formulations are not bioequivalent, do not substitute chewable tablets for the 400 mg film-coated tablet *Safety profile similar to that observed in adults *Information on dosing, adverse reactions, clinical trial and PK parameters *New dosage form
|
Antiviral
|
|
12/16/2011
|
Keppra
|
levetiracetam
|
Adjunctive therapy in the treatment of partial onset seizures
|
* Expanded indication to include pediatric patients from 1 month - <4 years; previously approved for use in 4 years and older* In pediatric patients 1 month - < 4 years of age, 17% experienced psychotic symptoms compared to 5% on placebo; irritability was reported in 11.7% of the Keppra-treated patients compared to 0% of placebo patients* Information on dosing, clinical trial, adverse reactions
|
Anticonvulsant
|
|
12/16/2011
|
Prezista
|
darunavir
|
Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older and weighing at least 10 kg
|
* Expanded indication to pediatric patients 3 years and older weighing at least 10 kg; previously approved for use in 6 years and older* Do not use in pediatric patients < 3 years of age* Information on dosing, adverse reactions, pharmacokinetics and clinical trial* New formulation
|
Antiviral
|
|
12/16/2011
|
Maxalt and Maxalt-MLT
|
rizatriptan
|
Treatment of migraine
|
* Expanded indication to include pediatric patients from 6 - 17 years. Safety and effectiveness in this age group was established in an adequate and well-controlled trial.* Safety and effectiveness in pediatric patients under 6 years of age have not been established.* Efficacy and safety of treatment with more than one dose of Maxalt within 24 hours in patients 6 to 17 years of age have not been established* Maxalt should not be prescribed to propranolol-treated pediatric patients who weigh < 40 kg (88 lb)* The incidence of adverse reactions in the pediatric clinical trial was similar between treatment and placebo groups. The adverse reaction pattern in pediatric patients is expected to be similar to adults* Hallucination, abnormal coordination, disturbance in attention, and presyncope occurred infrequently in pediatric patients in the clinical trial * Information on dosing, adverse reactions, clinical trial, and overdose
|
Antimigraine
|
|
12/15/2011
|
Nexium
|
esomeprazole
|
Erosive esophagitis due to acid-mediated gastroesophageal reflux disease
|
* Expanded age range to include pediatric patients 1 month to <1 year. Previously approved in 1-17 years. Use in 1 month to <1 year is supported by extrapolation of studies for adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients * Safety and effectiveness have not been established in neonates* Information on weight-based dosing, adverse reactions, clinical study
|
Antiulcerative
|
|
12/14/2011
|
Advate
|
Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method*
|
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A
|
See Package Insert for new information on biologics
|
Antihemophilic Factor
|
|
11/10/2011
|
HEMACORD
|
hematopoietic progenitor cells, cord blood*
|
For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
|
See Package Insert for new information on biologics
|
Somatic Cell
|
|
11/09/2011
|
Chantix
|
varenicline
|
Smoking cessation
|
* Safety and effectiveness of Chantix in pediatric patients have not been established; Chantix is not recommended for use in patients < 18 years of age* Information on single and multiple-dose pharmacokinetics of varenicline have been investigated in pediatric patients 12 - 17 years * Postmarketing study
|
Smoking cessation
|
|
10/18/2011
|
Ixempra Kit
|
ixabepilone
|
Advanced or refractory solid tumors
|
* The effectiveness in pediatric patients has not been established * Ixempra was evaluated in one Phase 1 and one Phase 2 trial * Adverse reactions were similar to adults, and no new safety signals were identified
|
Antineoplastic
|
|
10/17/2011
|
Reyataz
|
atazanavir
|
Treatment of HIV - 1 infection
|
* Revised pediatric dosing; Unified dosing for treatment-naive and treatment experienced patients and extended the use of ATV/RTV to treatment-experienced patients weighing 15 to 25 kg* New dosing regimen
|
Antiviral
|
|
08/22/2011
|
Copegus and PEGASYS
|
ribavirin and peginterferon alfa-2a
|
Treatment of chronic hepatitis C in patients 5 to 17 years of age
|
* Extended indication from adults to pediatric patients 5-17 years* Safety and effectiveness of PEGASYS, alone or in combination with COPEGUS in patients < of 5 years have not been established* Pediatric patients treated with PEGASYS plus COPEGUS combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline. At the end of 2 years follow-up after treatment, most patients returned to baseline normative growth curve percentiles for weight and height* Decreases in hemoglobin, neutrophils and platelets may require dose reduction or permanent discontinuation from treatment * If toxicities occur which may be related to PEGASYS or COPEGUS administration, the dose of one or both can be modified* Adverse reactions were similar to adults* Information on dosing, clinical trial, and adverse reactions
|
Antiviral
|
|
07/22/2011
|
GAMMAGARD LIQUID
|
Immune Globulin Infusion (Human)*
|
Treatment of patients with primary immunodeficiency associated with defects in humoral immunity in adults and pediatric patients two years of age or older
|
See Package Insert for new information on biologics
|
Immunomodulator
|
|
07/19/2011
|
CERVARIX
|
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant*
|
Postmarketing Study
|
See Package Insert for new information on biologics
|
Preventive Vaccine
|
|
07/15/2011
|
Topamax
|
topiramate
|
Monotherapy for partial onset or primary generalized tonic-clonic seizures
|
* Expanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older * Information on weight based dosing in 2 to < 10 years* Postmarketing study
|
Anticonvulsant
|
|
06/15/2011
|
Zenpep
|
pancrelipase
|
Postmarketing study
|
* New dosage strength of 3,000 USP lipase units to allow for dosing in infants less than 12 months* Postmarketing study
|
Pancreatic enzyme
|
|
06/10/2011
|
Creon
|
pancrelipase
|
Postmarketing study
|
* New dosage strength of 3,000 USP lipase units to allow for dosing in infants less than 12 months* Postmarketing study
|
Pancreatic enzyme
|
|
06/01/2011
|
KEDBUMIN
|
Albumin (Human)*
|
Hypovolemic shock, Hypoalbuminemia, Prevention of central volume depletion after paracentesis due to cirrhotic ascites, Ovarian Hyperstimulation Syndrome (OHSS), Adult Respiratory Distress Syndrome (ARDS), Burns, Hemodialysis patients undergoing long term dialysis, Patients who cannot tolerate substantial volumes of salt solution, Priming solution for cardiopulmonary bypass
|
See Package Insert for new information on biologics
|
albumin
|
|
05/17/2011
|
Faslodex Injection
|
fulvestrant
|
Use in girls with progressive precocious puberty associated with McCune-Albright Syndrome
|
* Efficacy has not been demonstrated in girls with McCune-Albright Syndrome associated with progressive precocious puberty* Information on dosing, adverse reactions, pharmacokinetics and clinical trial
|
Estrogen lowering agent
|
