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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 665
n = 601 with New Pediatric Studies; n = 64 with No New Pediatric Studies
BPCA only = 171; BPCA + PREA = 88; PREA only = 356; Rule = 49; None = 1

Pediatric Labeling Changes as of December 310, 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:  665
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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
08/24/2015 Promacta eltrombopag Treatment of thrombocytopenia in adult and pediatric patients one year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy *Safety and efficacy in pediatric patients 1 year and older with chronic ITP were evaluated in two double-blind, placebo-controlled trials. *Safety and efficacy in pediatric patients younger than 1 year with ITP have not yet been established. *Safety and efficacy in pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia have not been established. *Patients with East Asian ancestry have higher eltrombopag exposure. Dosing adjustments are needed in pediatric patients 6 years and older with East Asian ancestry and in hepatic impairment. *Information on dosing, preparation of oral suspension, PK parameters, clinical trials, adverse events.
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
07/15/2015 TachoSil Absorbable Fibrin Sealant Patch* Secondary treatment of local bleeding in adult and pediatric patients undergoing hepatic resection surgery See Package Insert for new information on biologics
07/15/2015 Epiduo Forte adapalene and benzoyl peroxide Treatment of acne vulgaris in patients 12 years and older *New higher strength combination formulation approved in adults and patients 12 years and older. *Safety and effectiveness in pediatric patients under the age of 12 have not been established. *Information on PK, adverse reactions, and clinical trial in adults and pediatric patients. *New dosage form. Antiacne, topical
06/26/2015 Kaletra lopinavir/ ritonavir Treatment of HIV-1 infection * Kaletra should not be administered once daily in pediatric patients. * A multicenter, open-label study evaluated the efficacy and safety of twice-daily versus once-daily dosing of Kaletra tablets dosed by weight in 173 virologically suppressed HIV-1 infected children. * New dosing regimen, postmarketing study. Antiviral
06/19/2015 Fycompa perampanel Treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older * Safety and efficacy in pediatric patients 12 years and older was established in a randomized double-blind, placebo-controlled, multicenter trial, which included 11 pediatric patients 12 to 16 years exposed to Fycompa; an additional 6 patients were treated with Fycompa in the open label extension of the study * Safety and effectiveness in pediatric patients less than 12 years of age have not been established * Adverse reactions were similar to those observed in adults * Information on dosing, PK, clinical studies, and adverse reactions * New indication Anticonvulsant
06/12/2015 Zomig Nasal Spray zolmitriptan Acute treatment of migraine with or without aura in adolescents 12 to 17 years old * Efficacy in pediatric patients 12 to 17 years was established in a placebo-controlled study with 81 pediatric patients receiving Zomig 2.5 mg and 229 pediatric patients receiving Zomig 5 mg * Safety of Zomig nasal spray in the acute treatment of migraine in pediatric patients 12 to 17 years of age was established i n two studies * Safety and effectiveness of in pediatric patients under 12 years have not been established * Adverse reactions were similar to those observed in adults * Information on dosing, clinical trials, adverse reactions * Postmarketing study Antimigraine
05/27/2015 Asacol mesalamine*** Maintenance of remission of mildly to moderately active ulcerative colitis *Safety and effectiveness for the maintenance of remission of mildly to moderately active ulcerative colitis in pediatric patients have not been established *Efficacy was not demonstrated in a randomized, double-blind 26-week trial of two dosage levels in 39 patients aged 5 to 17 years Anti-inflammatory
05/18/2015 Lamictal lamotrigine Maintenance treatment of bipolar disorder * Safety and efficacy for the maintenance treatment of bipolar disorder were not established in a double-blind, placebo-controlled trial that evaluated 301 pediatric patients aged 10 to 17 *Information on clinical trial and adverse reactions *Postmarketing study Anticonvulsant; Mood Stablizer
05/14/2015 IXINITY Coagulation Factor IX (Recombinant)* Indicated in adults and children equal to or greater than 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management See Package Insert for new information on biologics Antihemophilic Factor
05/14/2015 Treximet sumatriptan/naproxen Acute treatment of migraine with or without aura * Safety and efficacy for the acute treatment of migraine in pediatric patients 12 to 17 years of age were established in a double-blind, placebo-controlled trial *Safety and effectiveness in pediatric patients under 12 years of age have not been established *The safety of treating an average of more than 2 migraine headaches in pediatric patients in a 30-day period has not been established *Information on dosing, adverse reactions, pharmacokinetics clinical studies *Postmarketing study Antimigraine
04/27/2015 Tarceva erlotinib Recurrent or refractory ependymoma *Safety and effectiveness in pediatric patients have not been established. * In an open-label, multi-center trial, 25 pediatric patients (median age 14 years, range 3-20 years) with recurrent or refractory ependymoma were randomized to Tarceva or etoposide. * Safety and effectiveness in pediatric patients have not been established. * In an open-label, multi-center trial, 25 pediatric patients (median age 14 years, range 3-20 years) with recurrent or refractory ependymoma were randomized to Tarceva or etoposide. * The trial was terminated prematurely for lack of efficacy. * No new adverse events were identified in the pediatric population. * Information on clinical trial and population pharmacokinetics Antineoplastic
04/23/2015 Valcyte valganciclovir Prevention of cytomegalovirus disease in heart transplant patients *Extended indication down to 1 to 4 months; previously approved in 4 months and older. *Extended the duration of dosing regimen from 100 days to 200 days post-transplantation for the prevention of CMV disease in pediatric kidney transplant patients 4 months to 16 years. *Safety and efficacy have not been established in children for prevention of CMV disease in pediatric liver transplant patients, in kidney transplant patients less than 4 months of age, in heart transplant patients less than 1 month of age, in pediatric AIDS patients with CMV retinitis, and in infants with congenital CMV infection. *Monitor serum creatinine levels regularly and consider changes in height and body weight and adapt the dose as appropriate during prophylaxis period. *Higher incidence of neutropenia in the two pediatric studies as compared to adults, but there was no correlation between neutropenia and infections observed in the pediatric population. *The overall safety profile was similar with the extension of prophylaxis until Day 200 posttransplant in high risk pediatric kidney transplant patients. However, the incidence of severe neutropenia was higher in pediatric kidney transplant patients treated with VALCYTE until Day 200 (17/57, 30%) compared to pediatric kidney transplant patients treated until Day 100 (3/63, 5%). *Information on dosing, pharmacokinetics, clinical studies Antiviral
04/17/2015 Aptensio XR methylphenidate hydrochloride Attention Deficit Hyperactivity Disorder *Safety and effectiveness of have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials. * Safety and effectiveness in pediatric patients under six years have not been evaluated. *The long-term efficacy of methylphenidate in pediatric patients has not been established. * CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor weight and height in pediatric patients treated with CNS stimulants, including Aptensio XR. Pediatric patients not growing or gaining weight as expected may need to have their treatment interrupted. * Information on dosing, adverse reactions, and clinical trials CNS Stimulant
03/31/2015 ProAir RespiClick albuterol sulfate Treatment or prevention of bronchospasm and prevention of exercise induced bronchospasm *Safety and effectiveness for the treatment or prevention of bronchospasm in children 12 - 17 years and older with reversible obstructive airway disease is based on two12-week clinical trials, one long-term safety study and one -single-dose cross over study *The safety and effectiveness for treatment of exercise-induced bronchospasm in children 12 years of age and older is based on one single dose crossover study *The safety profile for patients 12 to 17 years was consistent with the overall safety profile seen in adults *The safety and effectiveness in pediatric patients below the age of 12 years have not been established. 120 children with asthma ages 4 to 11 years participated in the clinical program *Information on clinical trials, and adverse reaction information in adults and children 12 years and older *New dosage form Antiasthma
03/27/2015 Eovist gadoxetate disodium Postmarketing study *An adequate and well-controlled study was not conducted. An observational study was performed in 52 patients 2 months and less than18 years with suspected or known focal liver lesions. Eovist improved border delineation and increased contrast of the lesion in the majority of patients when compared to non-contrast images. *Safety and effectiveness have not been established in premature infants *No new safety issues were identified *No case of nephrogenic systemic fibrosis associated with Eovist or any other Gadolinium-based contrast agent has been identified in pediatric patients ages 6 years and younger *Postmarketing study Medical Imaging
03/26/2015 Oraltag iohexol Computed tomography of the abdomen and pelvis *Safety and effectiveness of oral iohexol have been established in pediatric patients *Information on dosing and preparation and administration instructions *New dosage form Medical Imaging
03/24/2015 Quadracel Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine Indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis See Package Insert for new information on biologics Preventative vaccine
03/23/2015 Ziagen abacavir HIV * Labeling revised to provide for once-daily dosing in pediatric patients 3 months of age *Information on clinical trial *Postmarketing study Antiviral
03/23/2015 Epivir lamivudine HIV * Labeling revised to provide for once-daily dosing in pediatric patients 3 months of age *Information on clinical trial *New dosing Antiviral
03/18/2015 Intuniv guanfacine Long-term maintenance treatment of ADHD *Information added to labeling regarding a long-term, placebo-controlled monotherapy maintenance trial in 6-17 years *Increases in mean systolic and diastolic blood pressure, of approximately 3 mmHg and 1 mmHg respectively, above original baseline were observed upon discontinuation of Intuniv *Information on adverse reactions and clinical trial *Postmarketing study Non-stimulant ADHD treatment
03/12/2015 Xopenex HFA Inhalation levalbuterol Asthma or reactive airway disease *Not indicated for pediatric patients less than 4 years of age. A 4 week randomized, placebo-controlled clinical trial in pediatric patients below the age of 4 years showed no statistical significant difference between treatment groups in the primary efficacy endpoint *There was an increased incidence of asthma-related adverse reactions reported in Xopenex HFA-treated pediatric patients compared to placebo in this age group *Information on clinical trial *Postmarketing study Antiasthmatic
03/12/2015 Saphris asenapine Treatment of Schizophrenia and Acute Manic or Mixed Episodes Associated with Bipolar I Disorder *Bipolar I Disorder *Safety and efficacy were established in a 3-week, placebo-controlled, double-blind trial of 403 pediatric patients ages 10 to 17 years, at fixed doses ranging from 2.5 mg – 10 mg twice daily *Safety and efficacy in patients less than 10 years of age have not been evaluated *In a Phase 1 study, pediatric patients aged 10 to 17 years appeared to be more sensitive to dystonia when the recommended dose escalation schedule for initial dosing was not followed *Adverse reactions: somnolence, dizziness, dysgeusia, oral paresthesia, nausea, increased appetite, fatigue, increased weight. Fatigue dose related *Monitor weight compared to expectations for normal growth. Weight gain (greater than or equal to 7%. increase in body weight) higher than placebo , Saphris 2.5 mg twice daily, 5 mg twice daily and 10 mg twice daily (1.1%, 12%, 8.9% and 8 % respectively) *No additional new major safety findings were reported from a 50-week, open-label, uncontrolled safety *Safety and efficacy for adjunctive therapy in the treatment of bipolar I disorder have not been established in the pediatric population. *Schizophrenia *Efficacy was not demonstrated in an 8-week, placebo-controlled, double-blind trial, in 306 adolescent patients aged 12 to17 years with schizophrenia *Safety and efficacy in patients less than 12 years have not been evaluated, *The most common adverse reactions reported were somnolence, akathisia, dizziness, and oral hypoesthesia or paresthesia. * Monitor weight gain compared with tht expected for normal growth. Increases in body weight of at least 7% increase in body weight at endpoint compared to baseline for placebo, Saphris 2.5 mg twice daily, and Saphris 5 mg twice daily was 3%, 10%, and 10%, respectively *Adverse reactions identified in the pediatric schizophrenia trial were generally similar to those observed in the pediatric bipolar and adult bipolar and schizophrenia trials *No new major safety findings were reported from a 26-week, open-label safety trial in pediatric patients with schizophrenia treated with Saphris monotherapy *Information on dosing, adverse reactions, lab abnormalities, and clinical trials *Postmarketing study Antipsychotic
02/26/2015 Liletta levonorgestrel-releasing intrauterine system Prevention of pregnancy for up to 3 years *Safety and efficacy have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal females under 16 years and for users 16 years and older *Use before menarche is not indicated *New drug Contraceptive
02/20/2015 Astepro Nasal Spray azelastine Seasonal allergic rhinitis; Perennial allergic rhinitis *One 4-week open-label study of 191 pediatric patients from 6 months to 5 years established safety and reduced allergic rhinitis sympsoms. These data supported treatment of: * Seasonal allergic rhinitis in patients aged 2 though 6 years, including dosing information *Perennial allergich rhinitis in pediatric patients aged 6 months through 6 years, including dosing information. *The safety and effectiveness of ASTEPRO in patients below 6 months of age have not been established Antiallergy

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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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