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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 731
n = 664 with New Pediatric Studies; n = 67 with No New Pediatric Studies
BPCA only = 182; BPCA + PREA = 104; PREA only = 396; Rule = 49

Pediatric Labeling Changes as of March 31, 2018

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, press the pediatric labeling date in the first column of the database to reveal the additional information. To view all records in the database, press 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 press 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:  731
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
03/22/2018 Symfi efavirenz, lamivudine and tenofovir disoproxil fumarate Treatment of HIV-1 infection in adult and pediatric patients weighing at least 40 kg *Safety and effectiveness of Symfi as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 40 kg have been established based on clinical studies using the individual components (efavirenz, lamivudine, and tenofovir disoproxil fumarate). *New drug. Antiviral
03/05/2018 Latuda lurasidone hydrochloride Treatment of children and adolescents with major depressive episodes associated with bipolar I disorder *Safety and effectiveness for the treatment of bipolar depression in pediatric patients 10 to 17 years was established in a 6-week, placebo-controlled clinical study in 347 pediatric patients. *Safety and effectiveness have not been established in pediatric patients less than 10 years of age with bipolar depression. *In the 6-week, placebo-controlled bipolar depression study in pediatric patients 10 to 17 years, somnolence was reported by 11.4% (20/175) of patients treated with Latuda compared to 5.8% (10/172) of placebo treated patients. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study. Antipsychotic
03/02/2018 Otiprio Otic Suspension ciprofloxacin Treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus *Safety and effectiveness for the treatment of acute otitis externa was established in 67 pediatric patients (3 through 17 years of age) who participated in the Phase 3 trial; 57% of patients were 3 through 11 years of age and 43% of patients were 12 through 17 years of age. *Safety and effectiveness in infants below 6 months of age have not been established. *The adverse reactions in pediatric patients were similar to those observed in adults. *Information on clinical trial. *New indication. Antibiotic, topical
02/28/2018 Cimduo lamivudine and tenofovir disoproxil fumarate Treatment of HIV-1 infection in adult and pediatric patients weighing at least 35 kg *Safety and effectiveness as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 35 kg have been established based on clinical studies using the individual components. *Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue CIMDUO as clinically appropriate. *New drug. Antiviral
02/20/2018 Luzu cream luliconazole Tinea pedis and tinea cruris *Safety and effectiveness in pediatric patients 12 to <18 years with tinea pedis and tinea cruris have been established by evidence from well-controlled trials in adult and pediatric patients and a pharmacokinetic study in pediatric patients. *Safety and effectiveness in pediatric patients 2 to <18 years of age with tinea corporis have been established by evidence from a well-controlled trial in pediatric patients. *Postmarketing study. Antifungal, topical
02/15/2018 Cialis tadalafil Duchenne muscular dystrophy *Not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established. *A randomized, double-blind, placebo-controlled trial in pediatric patients 7 to 14 years with Duchenne muscular dystrophy failed to demonstrate any benefit of treatment on a range of assessments of muscle strength and performance. Peripheral Vasodilator
02/06/2018 Pristiq desvenlafaxine Major Depressive Disorder (MDD) *Safety and effectiveness have not been established in pediatric patients for the treatment of MDD. *Efficacy was not demonstrated in two adequate and well controlled, 8-week, randomized, double-blind, placebo-controlled, parallel group studies conducted in 587 patients 7 to 17 years for the treatment of MDD. *Antidepressants, such as Pristiq, increase the risk of suicidal thoughts and behaviors in pediatric patients. *Pristiq was associated with a decrease in body weight in placebo-controlled trials in pediatric patients with MDD. The incidence of weight loss was 22%, 14%, and 7% for patients treated with low dose Pristiq, high dose Pristiq, and placebo, respectively. *The risks associated with longer term Pristiq use were assessed in 6-month, open-label extension studies in pediatric patients 7 to 17 years with MDD. *Postmarketing study. Antidepressant
02/05/2018 Symfi Lo efavirenz, lamivudine and tenofovir disoproxil fumarate HIV-1 infection in adult and pediatric patients weighing at least 35 kg *Safety and effectiveness of Symfi Lo as a fixed-dose tablet in pediatric patients infected with HIV-1 and weighing at least 35 kg have been established based on clinical studies using the individual components. *New dosage form. Antiviral
01/11/2018 Fluarix Quadrivalent Influenza Vaccine* For active immunization of persons 6 months and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine See Package Insert for new information on biologics Preventive Vaccine
12/26/2017 Draximage DTPA Technetium Tc99m Pentetate Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation and for renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate *Indicated in pediatric patients ages birth to less than 17 years of age. *Pediatric use is supported by evidence from controlled studies in adults and dosing and safety are based on clinical experience. *The radiation risk of Technetium Tc 99m pentetate is greater in pediatric patients than adults. *New route of administration and new indication. Medical imaging
12/22/2017 Procysbi cysteamine bitartrate Treatment-naïve nephropathic cystinosis patients 1 year and older *Expanded the indication to patients age 1 year and older; previously approved in 2 years and older. * Safety and effectiveness in pediatric patients under 1 years of age have not been established. *Adverse reactions in pediatric patients were similar to those in adults. *Information on dosing, PK parameters, and clinical trial.
12/22/2017 Lumify Ophthalmic Solution brimonidine tartrate Relief of redness of the eye due to minor eye irritations * Approved for use in adults and pediatric patients 5 years and older. *New formulation. Ophthalmologic hypotensive
12/11/2017 Xepi ozenoxacin Impetigo in adults, adolescents and children 2 months and older *Safety and effectiveness in the treatment of impetigo have been established in pediatric patients 2 months to 17 years of age. *Use in pediatric patients 2 months to 17 years of age is supported by evidence from adequate and well-controlled studies in which 251 pediatric patients received at least one dose of Xepi. *Safety and effectiveness in pediatric patients younger than 2 months of age have not been established. *Information on adverse reactions and clinical trials. Antibiotic, topical
12/08/2017 Omidria intraocular solution phenylephrine and ketorolac Prevention of intraoperative miosis and reduction of postoperative pain in patients who have undergone cataract surgery *Safety and effectiveness have been established in the pediatric population from neonates to adolescents (birth to younger than 17 years). * Use in this population is supported by evidence from adequate and well-controlled studies of Omidria in adults with additional data from a single active-controlled safety study in pediatric patients up to 3 years old. *The safety profile in children was similar to that observed in adults. *Information on adverse reactions and clinical trials. Analgesic, topical
12/06/2017 Jakafi ruxolitinib Relapsed or refractory solid tumors, leukemias or myeloproliferative neoplasms *The safety and effectiveness of Jakafi in pediatric patients have not been established. *Jakafi was evaluated in a single-arm, dose-escalation study in 27 pediatric patients with relapsed or refractory solid tumors and 20 with leukemias or myeloproliferative neoplasms. *A protocol-defined maximal tolerated dose was not observed, but since few patients were treated for multiple cycles, tolerability with continued use was not assessed adequately to establish a recommended Phase 2 dose. *The safety profile in children was similar to that observed in adults. *Information on dosing, and clinical trial. Hematology
11/22/2017 Isentress oral suspension raltegravir HIV exposed neonates ages 0-4 weeks and weighing at least 2 kg *Safety and pharmacokinetics of Isentress oral suspension were evaluated in 42 full-term HIV-1 exposed neonates at high risk of acquiring HIV-1 infection in a Phase 1, open-label, multicenter clinical study. *Not recommended in pre-term neonates or in pediatric patients weighing less than 2 kg. *Safety profile was similar to that observed in adults. *Postmarketing study. Antiviral
11/21/2017 Triumeq abacavir, dolutegravir, and lamivudine Treatment of HIV-1 infection in patients weighing at least 40 kg *Clinical data supporting use of Triumeq in HIV-1 infected pediatric patients weighing at least 40 kg is derived from previously conducted pediatric trials using the individual components of Triumeq. *Triumeq is a fixed-dose combination tablet which cannot be adjusted for patients weighing less than 40 kg. *Postmarketing study. Antiviral
11/14/2017 Fasenra benralizumab Add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype *Indicated in pediatric patients 12 years and older. *There were 108 adolescents aged 12 to 17 with asthma enrolled in the two Phase 3 exacerbation trials. *Safety and efficacy in patients younger than 12 years of age has not been established. *Adverse reactions were similar to those observed in adults. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *New drug. Antiasthmatic
11/14/2017 Tekturna aliskiren Treatment of hypertension in adults and children 6 years of age and older *Approved for use in adults and children 6 years and older. *Tekturna was evaluated in two randomized, double-blind clinical studies in pediatric patients 6 to 17 years of age. *Tekturna is contraindicated in children less than 2 years of age. Tekturna should not be used in children 2 to less than 6 years or in children who weigh less than 20 kg. *Preclinical studies indicate a potential for substantial increase in exposure to aliskiren in pediatric patients. *Information on administration of oral pellets. Do not chew or crush the contents of the capsules. *Adverse reactions were similar to those observed in adults. *Information on dosing, PK, and clinical trial. *Postmarketing study. Antihypertensive
11/03/2017 Vimpat lacosamide Treatment of partial-onset seizures to patients 4 years of age and older *Expanded the use of Vimpat tablets and oral solution for the treatment of partial-onset seizures to patients 4 years of age and older. *Use in this age group is supported by evidence from adequate and well-controlled studies in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 to less than 17 years of age. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Safety of Vimpat injection in pediatric patients has not been established. *In pediatric patients 4 years to less than 17 years of age, the recommended dosing regimen is based on body weight and is only recommended to be administered orally. *Adverse reactions were similar to those observed in adults. *Information on PK parameters, dosing, adverse reactions. *Postmarketing study. Anticonvulsant
10/13/2017 Stelara ustekinumab Psoriasis treatment of adolescent patients ages 12-17 years *Safety and effectiveness of have been established in pediatric subjects 12 to 17 years old with moderate to severe plaque psoriasis. Use of in this age group is supported by evidence from a multicenter, randomized, 60-week trial that included a 12-week, double-blind, placebo-controlled, parallel-group portion, in 110 pediatric subjects 12 years and older. *Safety and effectiveness for pediatric patients less than 12 years of age have not been established. *Adverse reactions observed in 12-17 years were similar to adults. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study Monoclonal antibody
10/13/2017 Pegays Pegfilgrastim Treatment of non-cirrhotic pediatric patients 3 years of age and older with HBeAg-positive Chronic Hepatitis B virus infection *Use for the treatment of pediatric patients 3 to 17 years of age with CHB is based on one clinical trial in 161 previously untreated CHB subjects 3 to 17 years of age of whom 111 were assigned to treatment with PEGASYS. *PEGASYS has not been studied in pediatric CHB patients with liver cirrhosis and the safety and efficacy in pediatric patients with CHB below the age of 3 years have not been established. *Growth inhibition was observed in CHB pediatric patients 3 to 17 years of age during therapy with PEGASYS lasting up to 48 weeks. *Adverse reactions observed in 3-17 years were similar to adults. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study Antiviral
10/13/2017 Butrans transdermal system buprenorphine Treatment of moderate-to severe chronic pain requiring continuous, around-the clock opioid treatment for an extended period of time *Safety and efficacy in patients under 18 years of age have not been established. *Butrans has been evaluated in an open-label clinical trial in pediatric patients. However, definitive conclusions are not possible because of the small sample size. *Postmarketing study. Analgesic
09/28/2017 Descovy emtricitabine and tenofovir alafenamide HIV-1 infected, virologically suppressed children weighing at least 25 kg *Safety and effectiveness of Descovy, in combination with other antiretroviral agents, for the treatment of HIV-1 infection was established in pediatric patients with body weight greater than or equal to 25 kg; previously approved in pediatric patients 12 to less than 18 years weighing at least 35 kg *Safety and effectiveness of Descovy coadminstered with an HIV-1 protease inhibitor that is administered with either ritonavir or cobicistat have not been established in pediatric subjects weighing less than 35 kg *Not recommended for patients weighing less than 25 kg. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study Antiviral
09/25/2017 Genvoya elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide *Approved for use in pediatric patients weighing at least 25 kg; previously approved in 12 to less than 18 years and weighing at least 35 kg. *Use in pediatric patients weighing at least 25 kg is supported by studies in adults and by an open-label trial in virologically-suppressed pediatric patients 6 to less than 12 years and weighing at least 25 kg, in which subjects were switched from their antiretroviral regimen to Genvoya. *Safety and effectiveness in pediatric patients less than 25 kg have not been established. *Safety profile in pediatric patients who received treatment was similar to that in adults. *Information on dosing, adverse reactions, and clinical trial.*Postmarketing study. Antviral
09/20/2017 Rapivab peramivir Treatment of acute uncomplicated influenza in patients 2 years and older *Expanded the patient population to include the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than two days based on clinical studies of 110 adolescent and pediatric patients. *Information on s dosing, adverse reactions, PK parameters, and clinical trials.
09/15/2017 Adzenys ER amphetamine Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older *Safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years of age in three adequate and well-controlled clinical trials of up to 4 weeks in duration. *Safety and efficacy in pediatric patients younger than 6 years of age with ADHD have not been established. *Growth should be monitored during treatment with stimulants, including ADZENYS ER, and children who are not growing or gaining weight as expected may need to have their treatment interrupted. * Information on dosing, adverse reactions, PK parameters, and clinical trials. CNS Stimulant
09/13/2017 Aptiom eslicarbazepine acetate Treatment of partial-onset seizures *Safety and effectiveness have been established in the age groups 4 to 17 years. *Use in these age groups is supported by evidence from adequate and well-controlled studies in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data from clinical studies in 393 pediatric patients 4 to 17 years of age. *Safety and effectiveness in pediatric patients below the age of 4 years have not been established. *Information on dosing, adverse reactions and PK parameters. *Postmarketing study Anticonvulsant
09/01/2017 Cubicin Injection daptomycin Staphylococcus aureus bacteremia *Safety and effectiveness in the treatment staphylococcus. aureus bloodstream infections (bacteremia) have been established in the age groups 1 to 17 years of age. *Use in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and from safety, efficacy and PK studies in pediatric patients with cSSSI and S. aureus bloodstream infections. *Safety and effectiveness in pediatric patients below the age of one year have not been established. *Cubicin has not been studied in pediatric patients with other bacterial infections. *Information on dosing, PK parameters, adverse reactions, and clinical trial. Antibiotic
08/31/2017 Afluria Quadrivalent Influenza Vaccine* Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine in pediatric patients 5 years of age and older See Package Insert for new information on biologics Preventive Vaccine
08/25/2017 Dotarem gadoterate meglumine Contrast agent for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity *Expanded indication down to term neonates; previously approved for use in 2 years and older. *A non-randomized study with 28 pediatric patients under 2 years who were referred for contrast MRI of the CNS supported extrapolation of CNS efficacy findings from adults and older children. *Safety has not been established in preterm neonates. *No cases of Nephrogenic Systemic Fibrosis associated with Dotarem or any other gadolinium-based contrast agents have been identified in pediatric patients age 6 years and younger. *Information on dosing, PK parameters, adverse reactions in pediatric patients, and clinical trial. Medical imaging
07/26/2017 Fycompa perampanel Monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older *Expanded the indication to include use as monotherapy for the treatment POS in patients with epilepsy aged 12 years and older; previously approved for use as adjunctive therapy. *New indication. Anticonvulsant
07/06/2017 Vimovo naproxen/esomeprazole magnesium Juvenile idiopathic arthritis (JIA) in adolescent patients 12 years of age and older weighing at least 38 kg *Safety and effectiveness have been established in adolescent patients 12 years and older weighing at least 38 kg for the symptomatic relief of JIA and to decrease the risk of developing naproxen-associated gastric ulcers. *Use in this age group is based on extrapolation of adequate and well-controlled studies in adults and supported by a 6 month safety study including pharmacokinetic assessment of naproxen and esomeprazole magnesium in 36 adolescent patients with JIA. *The safety profile in adolescent patients with JIA was similar to adults with RA. *Safety and effectiveness in pediatric patients less than 12 years or less than 38 kg with JIA have not been established. *Information on recommended dosing, and PK. *New indication. Anti-inflammatory
06/22/2017 Simponi golimumab Active polyarticular juvenile idiopathic arthritis *Effectiveness in pediatric patients less than 18 years of age has not been established. *Safety and efficacy were evaluated in a multicenter, placebo-controlled, double-blind, randomized-withdrawal, parallel group study in 173 children 2 to 17 years of age with active polyarticular juvenile idiopathic arthritis (pJIA) despite treatment with MTX for at least 3 months. *Adverse reactions were similar to those observed in adults. *Information dosing, and clinical trial. *Postmarketing study. Anti-inflammatory
06/20/2017 Mydayis mixed salts of a single-entity amphetamine Treatment of Attention Deficit Hyperactivity Disorder (ADHD) *Safety and effectiveness in pediatric patients with ADHD ages 13 to 17 years have been established in two placebo-controlled clinical studies. *Safety and effectiveness have not been established in pediatric patients ages 12 years and younger. *In clinical trials, pediatric patients 6 to 12 years of age experienced higher rates of adverse reactions in some cases compared to patients 13 years and older, including higher rates of insomnia (30% versus 8%) and appetite decreased (43% versus 22%). *Amphetamine systemic exposures (both d- and l-) in patients 6 to 12 years following a single dose were higher than those observed in adults at the same dose. *Information on PK parameters, adverse reactions and clinical trials. *New dosage form. CNS Stimulant
06/19/2017 Cotempla XR-ODT methylphenidate Treatment of Attention Deficit Hyperactivity Disorder (ADHD) *Safety and effectiveness have been established in pediatric patients 6 to 17 years in one adequate and well-controlled study in pediatric patients 6 to 12 years, pharmacokinetic data in adolescents, and safety information from other methylphenidate-containing products. *Safety and effectiveness in pediatric patients below 6 years of age have not been established. *The long-term efficacy of methylphenidate in pediatric patients has not been established. *Growth should be monitored during treatment with stimulants. *Information on dosing, adverse reactions, and clinical trial. *New dosage form. CNS Stimulant
06/15/2017 Calcium Gluconate calcium gluconate Treatment of acute symptomatic hypocalcemia *Safety and effectiveness have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia. *Pediatric approval is not based on adequate and well-controlled clinical studies. Safety and dosing recommendations in pediatric patients are based on published literature and clinical experience. *Concomitant use of ceftriaxone and calcium gluconate Injection is contraindicated in neonates (28 days or younger) due to reports of fatal outcomes associated with the presence of lung and kidney ceftriaxone-calcium precipitates. In patients older than 28 days, ceftriaxone and calcium gluconate Injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid. *This product contains up to 400 mcg/L aluminum which may be toxic, particularly for premature neonates due to immature renal function. Parenteral administration of aluminum greater than 4 to 5 mcg/kg/day is associated with central nervous system and bone toxicity. *New drug.
06/07/2017 FIBRYNA Fibrinogen (Human)* Treatment of acute bleeding episodes in adults and adolescents = 12 years of age with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia See Package Insert for new information on biologics
05/31/2017 Rebinyn Coagulation Factor IX (Recombinant), GlycoPEGylated* Approved for use in adults and children with hemophilia B for: (1) On-demand treatment and control of bleeding episodes; (2) Perioperative management of bleeding See Package Insert for new information on biologics
05/30/2017 Zerviate Ophthalmic Solution cetirizine Ocular itching associated with allergic conjunctivitis in patients 2 years of age and older *Safety and effectiveness have been established in pediatric patients two years of age and older. *Use in these pediatric patients is supported by evidence from adequate and well-controlled studies in pediatric and adult patients. *New dosage form. Antihistamine, topical
05/26/2017 Isentress HD raltegravir In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and in pediatric patients weighing at least 40 kg *New 600 mg film coated tablet approved for once daily use. *Isentress HD once daily has not been studied in pediatric patients. However population PK modeling and simulation support the use of 1200 mg (2 x 600 mg) once daily in pediatric patients weighing at least 40 kg. *New dosage form. Antiviral
05/23/2017 Sensipar cinacalcet Treatment of secondary HPT in pediatric patients with Chronic Kidney Disease on dialysis *Safety and efficacy for the pediatric population have not been established. *Use for the treatment of secondary HPT in pediatric patients with CKD on dialysis was evaluated in two randomized, controlled studies in 47 pediatric patients aged 6 years to less than 18 years and in one single-arm study in 17 pediatric patients aged 28 days to less than 6 years. *Dosing with Sensipar in pediatric study 1 was stopped because of a fatality in a Sensipar-treated individual who was noted to be severely hypocalcemic at the time of death. The cause of death was multifactorial and a contribution of Sensipar to the death could not be excluded. *Life threatening events and fatal outcomes associated with hypocalcemia have been reported in patients treated with Sensipar, including in pediatric patients. *Pediatric studies did not establish a safe and effective Sensipar dosing regimen for the pediatric population. *Information on safety, and clinical trials.
05/17/2017 Jevtana cabazitaxel Solid tumors *Safety and effectiveness in pediatric patients have not been established. *Jevtana was evaluated in 39 pediatric patients (ages 3 to 18 years) receiving prophylactic granulocyte - colony stimulating factor. No objective responses were observed in 11 patients with refractory high grade glioma or diffuse intrinsic pontine glioma. One patient had a partial response among the 9 patients with ependymoma. *Infusion-related/hypersensitivity reactions were seen in 10 patients (26%). Three patients experienced serious adverse events of anaphylactic reaction. The incidence of infusion related/hypersensitivity reactions decreased with steroid premedication. *The most frequent treatment-emergent adverse events were similar to those reported in adults. *Information on safety, dosing, PK parameters, and clinical trials. Antineoplastic
04/07/2017 Sovaldi sofosbuvir In combination with ribavirin for the treatment of chronic hepatitis C virus genotype 2 or 3 infection without cirrhosis or with compensated cirrhosis in pediatric patients 12 to 17 years of age or weighing at least 35 kg *Expanded the indication from adults to pediatric patients 12 years and older or weighing at least 35 kg. *Sovaldi was evaluated in an open-label clinical trial which included 50 patients 12 years of age and older. *Safety and efficacy have not been established in pediatric patients less than 12 years of age and weighing less than 35 kg with HCV genotype 2 or 3. Safety and efficacy have not been established in pediatric patients with HCV genotype 1 or 4. *Adverse reactions were similar to those observed in adults. *Information on dosing,clinical trial, and PK. Antiviral
04/07/2017 Harvoni ledipasvir and sofosbuvir Treatment of chronic hepatitis C virus genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis in pediatric patients 12 years of age and older or weighing at least 35 kg *Expanded the indication from adults to pediatric patients 12 years and older or weighing at least 35 kg. *Safety, pharmacokinetics, and efficacy for treatment of HCV genotype 1 infection in treatment-naïve and treatment-experienced pediatric patients 12 years of age and older without cirrhosis or with compensated cirrhosis have been established in an open-label, multicenter clinical trial. *Safety and efficacy have not been established in pediatric patients less than 12 years and weighing less than 35 kg, in pediatric patients with decompensated cirrhosis, or in pediatric liver transplant recipients. *Adverse reactions were similar to those observed in adults. *Information on dosing, clinical trial, and PK Antiviral
04/05/2017 Visipaque iodixanol 320 mgI/mL "Coronary computed tomography angiography (CCTA) to assist diagnostic evaluation of adults and pediatric patients 12 years and older with suspected coronary artery disease" *Approved for use for CCTA in adults and pediatric patients 12 years and older. *Safety and efficacy have not been established in pediatric patients less than 12 years for CCTA. *Pediatric patients at higher risk of experiencing an adverse reaction during and after administration of any contrast agent may include those with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, congestive heart failure, or a serum creatinine greater than 1.5 mg/dL. Pediatric patients with immature renal function or dehydration may be at increased risk for adverse events due to slower elimination of iodinated contrast agents. *Information on safety, and dosing. *New indication. Medical imaging
03/30/2017 Orencia abatacept Treatment of moderately to severely active Polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older *Approved for use in pJIA in pediatric patients 2 years and older as monotherapy or concominatly with methotrexate. *For pJIA, Orencia may be administered as an intraveneous infusion in 6 years and older or a subcutaneous injection in 2 years and older. Intraveneous dosing has not been studied in pediatric patients younger than 6 years of age. *Orencia with intravenous administration has not been studied in patients younger than 6 years of age. *Efficacy of Orencia for subcutaneous injection in children 2 to 17 years of age is based on pharmacokinetic exposure and extrapolation of established efficacy of intravenous Orencia in polyarticular JIA patients and subcutaneous Orencia in patients with RA. *Safety and efficacy of Orencia ClickJect autoinjector for subcutaneous injection have not been studied in patients under 18 years of age. *Safety and efficacy in pediatric patients for uses other than juvenile idiopathic arthritis have not been established. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, immunogenicity, dosing, clinical trials. *Postmarketing study. Anti-inflammatory
03/29/2017 Cubicin Injection daptomycin Complicated skin and skin structure infections (cSSSI) in pediatric patients 1 to 17 years of age *Safety and effectiveness in the treatment of cSSSI has been established in the age groups 1 to 17 years. Use in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and data from a safety, efficacy and PK study in pediatric patients 1 to 17 years of age with cSSSI. * Safety and effectiveness in pediatric patients below the age of one year have not been established. Avoid use of Cubicin in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems observed in neonatal dogs. * Not indicated in pediatric patients with renal impairment because dosage has not been established in these patients. * The safety profile in pediatric patients was similar to that observed in adult patients. * Information on dosing, administration, adverse reactions, PK, and clinical trial. * Postmarketing study. Antibiotic
03/21/2017 Ciloxan ophthalmic solution ciprofloxacin Bacterial conjunctivitis in pediatric patients less than 1 month old *Expanded the indication down to pediatric patients less than 1 year; previously approved for 1 year and older. *Information on clinical trial in pediatric patients birth to 31 days. Antibiotic, topical
03/21/2017 Zymar Ophthalmic Solution gatifloxacin Bacterial conjunctivitis in pediatric patients less than 1 month of age *Expanded the indication down to pediatric patients less than 1 year; previously approved for 1 year and older. *Information on clinical trial in pediatric patients birth to 31 days. Antibiotic, topical

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

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

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

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

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

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