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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 637
n = 575 with New Pediatric Studies; n = 62 with No New Pediatric Studies
BPCA only = 169; BPCA + PREA = 87; PREA only = 331; Rule = 49; None = 1

Pediatric Labeling Changes as of June 31, 2016

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:  637
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
06/30/2016 Kovanaze Nasal Spray tetracaine HCl and oxymetazoline HCl Regional anesthesia when performing a restorative procedure on teeth 4-13 and A-J in adults and children who weigh 40 kg or more *Approved in adults and children who weigh 40 kg or more *Kovanaze has not been studied in pediatric patients under 3 years and is not advised for use in pediatric patients weighing less than 40 kg because efficacy has not been demonstrated in these patients *Information on adverse reactions in adults and pediatric patients, clinical trial, PK * New drug
06/09/2016 Tivicay dolutegravir Treatment naïve or treatment experienced INSTI-naïve pediatrics patients weighing at least 30 kg to less than 40 kg *Expanded the indication to pediatrics patients weighing at least 30 kg; previously approved in 12 years and older weighing at least 40 kg * Safety and efficacy have not been established in pediatric patients weighing less than 30 kg or in any pediatric patients who are INSTI-experienced *Adverse reactions were similar to those observed in adults *Information on dosing, PK, and adverse reactions *Postmarketing study Antiviral
05/27/2016 Ativan Injection lorazepam Status epilepticus *Safety and effectiveness for status epilepticus have not been established in pediatric patients. *A randomized, double-blind, superiority-design clinical trial of Ativan versus intravenous diazepam in 273 pediatric patients ages 3 months to 17 years failed to establish efficacy for the treatment of status epilepticus. *Information on adverse reactions, and clinical trial Anticonvulsant
05/27/2016 Teflaro Injection ceftaroline fosamil Acute Bacterial Skin and Skin Structure Infections (ABSSI) and Community Acquired Bacterial Pneumonia (CABP) in pediatric patients 2 months to less than 18 years *Safety and effectiveness of Teflaro in the treatment of ABSSI and CABP have been established in pediatric patients 2 months to less than 18 years. *Use of Teflaro in these age groups is supported by evidence from adequate and well-controlled studies of Teflaro in adults with additional pharmacokinetic and safety data from pediatric trials. *Safety and effectiveness in pediatric patients below the age of 2 months have not been established as no data are available. *Safety findings were similar to those seen in the adult studies. *Information on dosing, PK , and adverse reactions. *Postmarketing study Antibiotic
05/25/2016 AFSTYLA Antihemophilic Factor (Recombinant), Single Chain* Indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes, (2) Routine prophylaxis to reduce the frequency of bleeding episodes, and (3) Perioperative management of bleeding See Package Insert for new information on biologics Antihemophilic Factor
05/23/2016 Flucelvax Influenza Vaccine* For active immunization of persons 4 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine See Package Insert for new information on biologics Preventive Vaccine
05/23/2016 Flucelvax Quadrivalent Influenza Vaccine* For active immunization of children and adolescents 4 years of age 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
04/29/2016 Entocort EC budesonide Treatment of mild to moderate active Crohn's disease in patients 8 years of age and older, and maintenance of remission in Crohn’s disease in patients ages zero to 17 years of age Mild to moderate active Crohn's disease * Safety and effectiveness have been established in pediatric patients 8 to 17 years who weigh more than 25 kg for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon. * Use in this age group is supported by evidence from adequate and well controlled studies of Entocort EC in adults, with additional data from 2 clinical studies in 149 pediatric patients treated up to 8 weeks and one pharmacokinetic study in 8 pediatric patients. * Safety and effectiveness have not been established in pediatric patients less than 8 years of age. Maintenance of remission in Crohn’s disease * Safety and effectiveness have not been established in pediatric patients for the maintenance of clinical remission of mild to moderate Crohn’s disease. * An open-label study to evaluate the safety and tolerability as maintenance treatment in pediatric patients aged 5 to 17 years did not establish the safety and efficacy of maintenance of clinical remission. * Safety profile is similar to safety profile observed in adults and no new safety concerns were identified. * Systemic corticosteroids, including Entocort EC, may cause a reduction of growth velocity in pediatric patients. * Pediatric patients with Crohn’s disease have a 17% higher mean systemic exposure and cortisol suppression than adults with Crohn’s disease. *Information on dosing, safety, clinical trials and PK. *Postmarketing study. Anti-inflammatory
04/29/2016 Fycompa perampanel Adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy 12 years of age and older and as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older * New Fycompa oral suspension has comparable bioavailability to Fycompa tablets under steady state. Both formulations may be used interchangeably. *Measure oral suspension using provided adaptor and dosing syringe. * Information on administration of oral suspension. *New formulation. Anticonvulsant
04/29/2016 Otovel Otic Solution ciprofloxacin and fluocinolone acetonide Treatment of acute otitis media with tympanostomy tubes in pediatric patients 6 months and older * Approved for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients aged 6 months and older, * Information on dosing, and clinical trials. * New drug. antibiotic/anti-inflammatory
04/28/2016 ProAir RespiClick albuterol sulfate Asthma in pediatric patients between the ages 4 to 11 years * Expanded the indication down to pediatric patients 4-11 years; previously approved in 12 years and older. * Safety and effectiveness in pediatric patients below the age of 4 years have not been established. * Information on dosing, adverse reactions, and clinical trials. * Postmarketing study Antiasthmatic
04/27/2016 Gadavist gadobutrol Evaluation of known or suspected supra-aortic or renal artery disease in adult and pediatric patients * Approved for use in adults and pediatric patients, including term neonates, to evaluate known or suspected supra-aortic or renal artery disease. * Information on clinical trials. * New indication. Medical Imaging
04/04/2016 Descovy emtricitabine and tenofovir alafenamide Treatment of HIV-1 infection in adults and pediatric patients 12 years of age or older * Efficacy and safety of Descovy was established in pediatric patents aged 12 years old with body weight greater than or equal to 35 kg. * Safety and effectiveness in pediatric patients less than 12 years or less than 35 kg have not been established. * Assessment of Bone Mineral Density should be considered for adults and pediatric patients treated with Descovy who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. * Information on dosing, clinical trial and PK. * New drug. Antiviral
03/31/2016 Lumason Sulfur Hexafluoride Lipid-Type A Microspheres Ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients * Effectiveness in pediatric patients has been established for use in ultrasonography of the liver for characterization of focal liver lesions from adequate and well controlled trials in adult patients and a clinical study of 44 pediatric patients. Safety was based on evaluation of published literature involving use of Lumason in over 900 pediatric patients. Non-fatal anaphylaxis was reported in one pediatric patient. * New indication Medical Imaging
03/23/2016 Cinqair reslizumab Asthma in patients 12 to 17 years * The safety and effectiveness in pediatric patients have not been established. * CINQAIR was evaluated in 39 patients aged 12 to less than 18 years with asthma in two 52-week exacerbation studies and one 16-week lung function study. In these studies, the asthma exacerbation rate was higher in adolescent patients treated with CINQAIR than placebo. * Information on clinical trials. * New drug Antiasthmatic
03/18/2016 Anthim obiltoxaximab Treatment of inhalational anthrax in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax * The effectiveness in adults and pediatric patients is based solely on efficacy studies in animal models of inhalational anthrax. * There have been no studies of safety or PK of ANTHIM in the pediatric population. * Information on dosing. * New drug
03/18/2016 OraVerse Injection phentolamine mesylate Reversal of soft-tissue anesthesia * Expanded indication down to pediatric patients 3 years and older; previously approved in 6 years and older. * Safety and efficacy have not been established in patients younger than 3 years. • Information on dosing and PK. * Postmarketing study
03/10/2016 Truvada emtricitabine/tenofovir disoproxil fumarate Treatment of HIV-1 infection in pediatric patients weighing at least 17 kilograms * Expanded the indication from pediatric patients 12 years and older down to pediatric patients weighing at least 17 kg. * Truvada should only be administered to HIV-1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a whole tablet. *Truvada has not been evaluated for use in pediatric patients weighing less than 17 kg. *Postmarketing study Antiviral
03/01/2016 Odefsey emtricitabine, rilpivirine, and tenofovir alafenamide Treatment of HIV-1 infection in patients 12 years of age and older * Safety and efficacy of Odefsey was established in pediatric patients 12 years and older weighing 35 kg or more. * Use of Odefsey in this age group is supported by adequate and well-controlled studies in adults with HIV-1 infection, and by 2 pediatric studies in 59 pediatric patients 12 to < 18 years. * Safety and efficacy have not been established in pediatric patients less than 12 years of age or weighing less than 35 kg. * Safety was similar to that observed in adults. * Information on clinical trials, adverse reactions. * New drug Antiviral
02/29/2016 Tetracaine Hydrochloride Ophthalmic Solution tetracaine hydrochloride For use in procedures requiring a rapid and short-acting topical ophthalmic anesthetic * Approved for use in adults and pediatric patients. * Safety in the pediatric population has been demonstrated in clinical trials. Efficacy for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population. * Information on dosing. * New drug. Antibiotic, topical
02/24/2016 Aczone Gel 7.5% dapsone Treatment of acne vulgaris in patients 12 years of age and older * Approved in adults and pediatric patients 12 years and older. * Safety and efficacy was evaluated in 1066 patients 12-17 years old. * Safety and effectiveness have not been established in pediatric patients below the age of 12 years. * Safety was similar to the vehicle control group. * Information on clinical trials, and adverse reactions in adults and pediatric patients 12 and older. * New Drug Anti-inflammatory, topical
02/23/2016 Complera emtricitabine/rilpivirine/tenofovir disoproxil fumarate Treatment of HIV-1 infection * Extended the indication from adults to pediatric patients in 12 to less than 18 years. *Safety and efficacy have not been established in pediatric patients less than 12 years or weighing less than 35 kg. * Pediatric trials have not been conducted using the emtricitabine, rilpivirine, tenofovir disoproxil fumarate fixed-dose combination tablets. Pediatric information is based on trials conducted with the individual entities. * Information on pharmacokinetics, and dosing. * Postmarketing study. Antiviral
02/03/2016 Prilosec omeprazole Short term treatment of erosive esophagitis due to gastroesophageal reflux disease in patients 1 month to less than 1 year of age * Safety and effectiveness have been established in pediatric patients 1 month to less than 1 year of age. * Use in this population is supported by adequate and well-controlled studies in adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients. * Safety and efficacy have not been establish in patients less than 1 month of age for any indication. *Adverse reactions frequently reported in the 1 month to <1 year age group include respiratory adverse reactions (42%), and otitis media (22%). Information on dosing, PK, adverse reactions. *Postmarketing study Antiulcerative
01/27/2016 Adzenys XR-ODT amphetamine Attention Deficit Hyperactivity Disorder in pediatric patients 6 to 17 * Safety and effectiveness have been established in pediatric patients 6 to 17 years in three clinical trials of up to 4 weeks in duration * Safety and efficacy in pediatric patients younger than 6 years of age have not been established. *Growth should be monitored during treatment with stimulants, including Adzenys XR-ODT, in pediatric patients 6 to 17 years who are not growing or gaining weight as expected because they may need to have their treatment interrupted. *Pediatric patients ages 6 to 12 years: Most common adverse reactions were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. Pediatric patients ages 13 to 17 years: Most common adverse reactions were loss of appetite, insomnia, abdominal pain, weight loss, and nervousness. *Information on dosing, adverse reactions, and clinical trials *New dosage form CNS Stimulent
01/15/2016 Readi-Cat 2 and Readi-Cat 2 Smoothie barium sulfate CT of the abdomen in pediatric patients *Approved for use in adults and pediatric patients *Information in dosing, adverse reactions *New dosage form Medical imaging
01/14/2016 HIBERIX Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) * Active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b in children 6 weeks through 4 years of age See Package Insert for new information on biologics Vaccine
01/11/2016 E-Z-HD barium sulfate For use in double contrast radiographic examinations of the esophagus, stomach and duodenum to visualize the gastrointestinal tract in patients 12 years and older *Approved for use in adults and pediatric patients 12 years and older *Safety and efficacy have not been approved in pediatric patients less than 12 years of age * Information on dosing, adverse reactions *New drug Medical imaging
12/17/2015 Emend aprepitant** Prevention of chemotherapy induced nausea and vomiting in patients ages 6 months of age and older *Safety and effectiveness of Emend oral suspension have been established in pediatric patients 6 months and older. *Safety and effectiveness have not been established in patients less than 6 months. *New dosage form. Antiemetic
12/10/2015 Otiprio ciprofloxacin otic suspension Treatment of pediatric patients 6 months and older with bilateral otitis media with effusion undergoing tympanostomy tube placement *Indicated in pediatric patients 6 months and older. *Safety and effectiveness was established in 530 pediatric patients with bilateral otitis media with middle ear effusion undergoing myringotomy with tympanostomy tube placement. The median age of patients enrolled in the clinical trials was 1.5 years. *The safety and effectiveness in infants below six months of age have not been established. *Information on administration, adverse reactions, and clinical trials. *New drug. Antibiotic, topical
12/04/2015 QuilliChew ER methylphenidate hydrochloride Attention Deficit Hyperactivity Disorder *Indicated for use in pediatric patients pediatric patients ages 6 to 17 years. *Use in these age groups is based on one adequate and well-controlled clinical study in pediatric patients 6 to 12 years old, pharmacokinetic data in adolescents and adults, and safety information from other methylphenidate-containing products. *The safety and effectiveness of in pediatric patients under six years have not been evaluated. *Long-term effectiveness of QuilliChew ER has not been established. *Growth should be monitored during treatment with CNS stimulants, including QuilliChew ER. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted. *Information on dosing, adverse events, clinical trial. *New dosage form. CNS stimulant
12/04/2015 Gamunex-C Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified* Primary Humoral Immunodeficiency in patients two years of age and older See Package Insert for new information on biologics
11/20/2015 Caldolor Injection ibuprofen Management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, and for the reduction of fever in pediatric patients 6 months and older *Expanded the indication down to pediatric patients 6 months and older; previously approved in adults *The effectiveness for the treatment of pain and fever has not been studied in pediatric patients less than 6 months. *Information on dosing, adverse reactions, and clinical trials *Postmarketing study Analgesic; Antipyretic
11/18/2015 Narcan Nasal Spray naloxone hydrochloride Emergency treatment of known or suspected opioid overdose *Safety and effectiveness of naloxone nasal spray have been established in adults and pediatric patients of all ages *Use of naloxone hydrochloride in pediatric patients is supported by evidence from adequate and well-controlled studies of naloxone hydrochloride in adults with additional data from 15 clinical studies (controlled and uncontrolled) in neonates and pediatric patients *Absorption of naloxone hydrochloride following intranasal administration in pediatric patients may be erratic or delayed. *Even when the opiate-intoxicated pediatric patient responds appropriately to naloxone hydrochloride, he/she must be carefully monitored for at least 24 hours, as a relapse may occur as naloxone is metabolized. *Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal. *Information on dosing *New dosage form Opioid antagonist
11/13/2015 ADYNOVATE Antihemophilic Factor (Recombinant), PEGylated* Adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency) for (1) on-demand treatment and control of bleeding episodes and (2) routine prophylaxis to reduce the frequency of bleeding episodes See Package Insert for new information on biologics
11/05/2015 Genvoya elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide Treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older *Indicated for adults and pediatric patients 12 years and older weighing at least 35 kg. *The pharmacokinetics, safety, and virologic and immunologic responses were evaluated in 23 treatment-naïve, HIV-1 infected patients 12 to less than 18 years through 24 weeks in an open-label trial *Safety and effectiveness in pediatric patients less than 12 years have not been established.*Among the 23 pediatric patients receiving Genvoya for 24 weeks, 2 patients had significant (greater than 4%) lumbar spine BMD loss at Week 24.*Information on dosing, PK, adverse reactions and clinical trials *New drug Antiviral
11/04/2015 Nucala mepolizumab Treatment in severe asthma in patients 12 years and older older and with an eosinophilic phenotype *Indicated for adults and pediatric patients 12 years and older * A total of 28 adolescents aged 12 to 17 years with asthma were enrolled in the phase 3 studies. *Safety and efficacy in pediatric patients less than 12 years have not been established. *Information on dosing, and clinical trials *New drug Antiasthmatic
10/19/2015 Dyanavel XR amphetamine Treatment of Attention Deficit Hyperactivity Disorder in 6 years and older *Safety and effectiveness have been established in pediatric patients with ADHD ages 6-17 years. *Safety and efficacy in pediatric patients younger than 6 years with ADHD have not been established. *Growth should be monitored during treatment with stimulants, including Dyanavel XR, and children who are not growing or gaining weight as expected may need to have their treatment interrupted. *The adverse reaction profile of Dyanavel XR appears similar to other amphetamine extended-release products. *Information on adverse reactions, dosing, PK, and clinical trial. *New dosage form CNS Stimulant
09/24/2015 Reyataz Oral Powder atazanavir HIV-1 *Expanded indication to patients 3 months and older weighing 5 to < 10 kg and to those weighing > 25 kg; previously approved in patients 3 months of age and older weighing at least 10 kg. *Not recommended for patients weighing less than 5 kg. *Information on PK, dosing and clinical trial. *Postmarketing study Antiviral
09/17/2015 Epzicom abacavir sulfate and lamivudine Once-daily dosing for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg *Expanded indication from adults to pediatric patients weighing at least 25kg. *Dosing recommendations in this population are based on the safety and efficacy established in a controlled trial conducted using either the combination of Epivir and Ziagen or Epzicom. *In pediatric patients weighing less than 25 kg, use of abacavir and lamivudine as single products is recommended. *The adverse reactions in pediatric patients are similar to those observed in adults. *Information on dosing, PK, clinical studies. Antiviral
09/15/2015 Spiriva Respimat Inhalation Spray tiotropium bromide "Long-term, once-daily, maintenance treatment of asthma in patients 12 *Safety and efficacy Spiriva Respimat 2.5 mcg have been established in patients 12 to 17 years with asthma in 3 clinical trials up to 1 year in duration. *In 3 clinical trials, 327 patients aged 12 to 17 years with asthma were treated with Spiriva Respimat 2.5 mcg. *Safety and efficacy of Spiriva Respimat have not been established in pediatric patients less than 12 years of age. *Adverse reactions in adolescents were similar to those observed in adults. *Information on dosing, adverse reactions and clinical trials in adults and adolescents. *New indication Antiasthmatic
09/14/2015 Velcade bortezomib Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) *Effectiveness in pediatric patients with relapsed pre-B ALL has not been established. *The activity and safety of Velcade in combination with intensive reinduction chemotherapy was evaluated in pediatric and young adult patients with lymphoid malignancies. There were 140 patients with ALL or LL enrolled and evaluated for safety. *No new safety concerns were observed Antineoplastic
09/09/2015 Delzicol mesalamine** Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older *Expanded the indication to pediatric patients 5 years and older; previously approved in 12 years and older. *Safety and effectiveness in pediatric patients below the age of 5 years have not been established. *Two Delzicol 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet. *For patients unable to swallow the capsules whole, information on opening the capsule(s) and swallowing the contents. *New dosage form Anti-inflammatory
09/04/2015 NUWIQ Antihemophilic Factor (Recombinant)* Indicated in adults and children with Hemophilia A fr on-demand treatment and control of bleeding episodes, perioperative management of bleeding and routine prophylaxis to reduce the frequency of bleeding episodes See Package Insert for new information on biologics Antihemophilic Factor
08/28/2015 Emend aprepitant Prevention of chemotherapy induced nausea and vomiting in patients ages 12 years to 17 years and patients less than 12 years who weigh at least 30 kg *Indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer (HEC) chemotherapy and moderately emetogenic cancer (MEC) chemotherapy in patients 12 years of age and older and patients less than 12 years who weigh at least 30 kg. *Although the safety and efficacy results from the trial in 302 pediatric patients support the use of Emend for the prevention of nausea and vomiting associated with HEC or MEC in pediatric patients 6 months to 12 years, there is no commercially available dosage form appropriate for patients less than 12 years of age and weighing less than 30 kg. *Safety and effectiveness for the prevention of nausea and vomiting associated with HEC or MEC have not been established in patients less than 6 months. *Safety and effectiveness have not been established for the prevention of postoperative nausea and vomiting in pediatric patients. *Adverse reactions were similar to those observed in adults. *Information on dosing, adverse events, PK, and clinical trial Antiemetic
08/26/2015 Edurant rilpivirine HIV-1 infection in treatment-naïve pediatric patients from 12 to less than 18 *Expanded the indication from adults to pediatric patients 12 to less than 18 years and weighing at least 32 kg. *Safety, efficacy and PK were evaluated in an open-label, Phase 2 trial that enrolled 36 antiretroviral treatment-naïve, HIV-1 infected pediatric patients. *Safety and effectiveness in pediatric patients less than 12 years have not been established. *Information added to Warnings on pediatric depression: During the Phase 2 trial, the incidence of depressive disorders was 19.4% (7/36). Most events were mild or moderate. The incidence of Grade 3 and 4 depressive disorders was 5.6% (2/36). Suicidal ideation and suicide attempt were reported in 1 subject. *The most common ADRs reported in at least 2 subjects (regardless of severity) include headache (19.4%), depression (19.4%), somnolence (13.9%), nausea (11.1%), dizziness (8.3%), abdominal pain (8.3), vomiting (5.6%) and rash (5.6%). *Information on dosing, adverse reactions, abnormal adrenal function, PK, and clinical trial
08/14/2015 Procysbi cysteamine bitartrate Treatment of nephropathic cystinosis in pediatric patients 2 years of age and older *Expanded indication to pediatric patients down to 2 years; previously approved in 6 years and older. *Safety and effectiveness in pediatric patients under 2 years of age have not been established. *Information on adding capsule contents to foods and liquids. *Information on dosing, and clinical trial extension
08/13/2015 Oxycontin extended release tablets oxycodone hydrochloride Management of pain severe enough to require daily, around the-clock, long-term opioid treatment in pediatric patients 11 years and older *Safety and efficacy have been established in pediatric patients 11 to 16 years. Use is supported by evidence from adequate and well-controlled trials in adults as well as an open-label study in pediatric patients ages 6 to 16 years. *There were insufficient numbers of patients less than 11 years of age enrolled in this study to establish the safety of the product in this age group. *The safety in pediatric patients was evaluated in 155 patients previously receiving and tolerating opioids for at least 5 consecutive days. *The most frequent adverse reactions observed in pediatric patients were vomiting, nausea, headache, pyrexia, and constipation. *Information on dosing, adverse reactions, and clinical trial Analgesic
08/05/2015 Wilate von Willebrand Factor/Coagulation Factor VIII Complex (Human)* On-demand treatment and control of bleeding episodes and perioperative management of bleeding See Package Insert for new information on biologics Coagulation Factor
07/30/2015 Gammaplex Immune Globulin Intravenous (Human) 5% Liquid* Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older See Package Insert for new information on biologics
07/23/2015 Aranesp darbepoetin alfa Initial treatment of anemia in pediatric patients with chronic kidney disease (CKD) *Expanded the indication from adults to pediatric patients. * Darbepoetin alfa was evaluated in a double-blind study in 114 pediatric patients from 1 to 18 years with CKD receiving or not receiving dialysis. * Information on recommended dosing, and clinical trial. * Postmarketing study. erythropoiesis-stimulating agent

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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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