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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database
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N = 470
n = 428 with New Pediatric Studies; n = 42 with No New Pediatric Studies
BPCA only = 153; BPCA + PREA = 63; PREA only = 205; Rule = 48; None = 1

Pediatric Labeling Changes as of May 21, 2013

This list highlights key pediatric information from the studies submitted in response to pediatric legislative initiatives. CBER regulated products have an asterisk (*) by the proper name. To obtain all the information for a pediatric labeling change, select the pediatric labeling date in the first column of the database to reveal the additional information. To view all records in the database, select the All button at the bottom of the page. To search for a specific pediatric labeling change, enter the trade name or generic name in the Filter box and select Show Items. Note: CBER and CDER regulated biologics with pediatric labeling changes before 9/27/2007 are excluded from the database.

Download New Pediatric Labeling Information Database data in Microsoft Excel web format Click on this link to download all data from the selected searchable database in Excel format. If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.


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   No. of Records Found:  471
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
01/04/2010 Xolair omalizumab Moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. * Safety and effectiveness were evaluated in 2 studies in 926 asthma patients 6 to <12 years of age. The risk-benefit assessment does not support use in patients 6 to <12 years considering the risk of anaphylaxis and malignancy seen in Xolair-treated patients e12 years and the modest efficacy of Xolair in the pivotal pediatric study * Studies in patients 0-5 years were not required due to safety concerns of anaphylaxis and malignancy * Information added to Pediatric Use Antiasthmatic
12/24/2009 Famvir famciclovir Treatment of children 1 month  12 years of age w/ herpes simplex (HSV) & 1  12 years w/ varicella zoster (VSV) * Available data are insufficient to support the use of famciclovir for the treatment of children with chickenpox or infections due to HSV * The PK profile and safety were studied in 2 open-label studies: (1) a single-dose PK and safety study in infants 1 month to <1 year of age who had an active herpes simplex virus (HSV) infection or who were at risk for HSV infection and (2) a single-dose PK, multiple-dose safety study in children 1 to <12 years of age with clinically suspected HSV or varicella zoster virus (VZV) infection * Information added to Pediatric Use Antiviral
12/22/2009 Flomax tamsulosin Treatment of elevated detrusor leak point pressure associated with neurological disorder * Efficacy and positive benefit/risk was not demonstrated in 2 studies (a randomized, double-blind, safety and efficacy study and an open label safety study) conducted in patients 2 -16 years * The most frequently reported adverse events from the 2 studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation. * Information added to Pediatric Use Urology
12/22/2009 Topamax topiramate Migraine Prophylaxis * Safety and effectiveness for migraine prevention in pediatric patients have not been established * Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study * Information added to Warnings and Precautions and Pediatric Use Anticonvulsant
12/22/2009 Topamax topiramate Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months * Effectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures * Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. * Information added to Warnings and Precautions and Pediatric Use Anticonvulsant
12/14/2009 Daytrana methylphenidate Postmarketing safety study * Information added to Warnings and Adverse Reactions on skin reactions observed in a postmarketing dermal study in pediatric patients CNS Stimulant
12/04/2009 Zyprexa olanzapine Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 * Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age * Safety and effectiveness in children < 13 years of age have not been established * Recommended starting dose for adolescents is lower than that for adults * Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels * Information on dosing, adverse reactions, pharmacokinetics, clinical studies Antipsychotic
12/02/2009 Seroquel quetiapine Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age * Extended schizophrenia indication from adults to adolescents 1317 years of age; extended bipolar mania indication from adults to children and adolescents 10-17 years of age * Safety and effectiveness in children < 13 years of age with schizophrenia have not been established; safety and effectiveness in children < 10 years of age with bipolar mania have not been established * Most adverse reactions in pediatric clinical trials were similar to those observed in adults and included somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, and weight increase. However, increases in blood pressure and potentially clinically significant increases in heart rate (> 110 bpm) occurred in children and adolescents and did not occur in adults. * Information on dosing, adverse reactions, pharmacokinetics, and clinical studies Antipsychotic
12/01/2009 Patanase olopatadine Seasonal allergic rhinitis * Expanded age range down to 6 years; previously approved for use in 12 years and older * Safety and effectiveness have not been established in < 6 years of age * The incidence of epistaxis (nosebleed) was higher in children 6 -11 years of age compared to the adult and adolescent population * Information on clinical trials, adverse reactions, and new one spray per nostril twice daily dosing in 6-11 years Antihistamine
11/19/2009 Abilify aripiprazole Irritability associated with autistic disorder * Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age * Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. * Information on dosing, adverse reactions, and clinical studies Antipsychotic
11/12/2009 Protonix pantoprazole GERD * Extended indication from adults to pediatric patients 5 years of age and older * Use in pediatric patients 1 to 16 years of age is supported by extrapolation from studies in adults, and safety, efficacy and PK studies performed in pediatric patients * There is no age-appropriate formulation available for patients less than 5 years of age * Effectiveness was not demonstrated in a clinical trial of patients 1 month to 11 months of age with symptomatic GERD * Safety and effectiveness for pediatric uses other than EE have not been established * Information on adverse reactions, pharmacokinetics, and clinical studies Antiulcerative
11/10/2009 AFLURIA Influenza Virus Vaccine* Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine See Package Insert for new information on biologics Preventive Vaccine
11/06/2009 Retrovir zidovudine Treatment of HIV-1 infection in combination with other antiretroviral agents * Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg Antiviral
10/23/2009 Focalin XR dexmethylphenidate ADHD * Revised maximum daily dosing due to dose-response studies. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended * Dosing should be individualized to patient needs and response. * There was no clear benefit of the higher doses compared to the lower doses. Adverse events and discontinuations were dose-related. * New dosing regimen; new dosage strength (30 mg capsule) CNS Stimulant
10/22/2009 Atacand candesartan Hypertension * Expanded indication from adults to pediatric patients 1 to < 17 years of age. * Children < 1 year must not receive candesartan. Administering drugs that act directly on the renin-angiotensin system can have effects on the development of immature kidneys * Children with glomerular filtration rate < 30ml/min/1.73m2 should not receive candesartan. * In clinical trials, 4 of 233 children experienced worsening renal disease * Information on preparation of an oral suspension, dosing and administration, adverse events, pharmacokinetics, and clinical trials Antihypertensive
10/19/2009 Fluarix Influenza Virus Vaccine* Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine See Package Insert for new information on biologics Preventive Vaccine
10/16/2009 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 16 and 18 See Package Insert for new information on biologics Preventive Vaccine
10/16/2009 GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 6 and 11 See Package Insert for new information on biologics Preventive Vaccine
10/15/2009 Crestor rosuvastatin Heterozygous familial hypercholesterolemia * New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years with heterozygous familial hypercholesterolemia * Has not been studied in children < 10 years or in pre-menarchal girls * Information on dose, adverse events and clinical studies Antilipemic
10/02/2009 Welchol colesevelam Heterozygous familial hypercholesterolemia * New indication for use as monotherapy or with a statin in boys and postmenarchal girls 10-17 years with heterozygous familial hypercholesterolemia * Has not been studied in children < 10 years or in pre-menarchal girls * Information on dose, adverse events and clinical studies Antilipemic
10/01/2009 Mirena levonorgestrel-releasing intrauterine system Treatment of heavy menstrual bleeding for women using intrauterine contraception * New indication for the treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception * Use before menarche is not indicated Contaceptive
09/18/2009 AndroGel testosterone Use in adolescent boys with delayed puberty * New safety information added to labeling including a Boxed Warning, and revisions to the Warnings and Precautions, Adverse Reactions, and Patient Counseling sections on the risk of virilization from secondary exposure of children to testosterone due to drug transfer from unwashed or uncovered application skin sites of adult males using testosterone gel products * Safety and efficacy have not been established in males < 18 years Androgen-anabolic steroid
09/08/2009 Bepreve Ophthalmic Solution bepotastine besilate Ocular itching associated with allergic conjunctivitis * Efficacy in pediatric patients 2 years to < 10 years based on clinical trials conducted in pediatric patients > 10 years and from adults * Safety and efficacy have not been established in pediatric patients < 2 years * New drug Antihistamine, topical
09/02/2009 Intuniv guanfacine ADHD * Efficacy established in 2 controlled clinical trials in children 6-17 years * Safety and efficacy in pediatric patients< 6 years have not been established * In clinical trials, there were dose and exposure-related risks for adverse events (AEs) including hypotension, bradycardia, and sedative events. Somnolence and sedation were reported in 38% on guanfacine vs. 12% on placebo in children and adolescents with ADHD, especially during initial use * Information on dosing, clinical trials, and AEs * New dosage form Non-stimulant ADHD treatment
08/31/2009 Astepro Nasal Spray azelastine hydrochloride Seasonal and perennial allergic rhinitis in patients 12 years of age and older. * Safety and efficacy for the treatment of seasonal and perennial allergic rhinitis were evaluated in 7 controlled clinical trials in patients 12 years and older * Information on clinical trials, dosing, and adverse events (AEs) * New indication (PAR) and dosing regimen Antihistamine
08/28/2009 Valcyte valganciclovir Prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients e 4 months of age * Use in pediatric patients e 4 months is based on efficacy data from a study in adults and PK, safety, and efficacy data from an open-label trial in pediatric solid organ transplant recipients at risk for developing CMV disease * The efficacy and safety have not been established in children for: 1. Prevention of CMV disease in liver transplant patients 2. Prevention of CMV disease in solid organ transplants other than those indicated 3. Prevention of CMV disease in pediatric solid organ transplant patients < 4 months of age 4. Treatment of congenital CMV disease * Adverse events (AEs) similar to adult patients, however, certain Aes including upper respiratory tract infection, pyrexia, nasopharyngitis, anemia, and neutropenia were reported more frequently in pediatric patients * Information on dosing, PK, and clinical study * New dosage form Antiviral
08/27/2009 Zenpep pancrelipase Exocrine pancreatic insufficiency due to cystic fibrosis * Safety and efficacy assessed in 2 studies which included pediatric patients ages 1-17 years * Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase with the same active ingredient. * High doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures in children <12 years of age * AEs similar to adults * Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce * Information on dosing, and clinical studies * Not interchangeable with other pancrelipase products * New drug Pancreatic enzyme
08/21/2009 Xyzal levocetirizine dihydrochloride Seasonal allergic rhinitis (SAR) in children 2 years of age and older; perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU) for children 6 months of age and older * Expanded age range for CIU down to 6 months; previously approved for use in 12 years and older * Expanded age range for PAR down to 6 months; previously approved for use in 6 years and older * Expanded age range for SAR down to 2 years; previously approved for use in 6 years and older * Pediatric use is supported by evidence from studies in adults with additional safety and PK data in pediatrics * Patient population altered Antihistamine
08/19/2009 HIBERIX Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) * Active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b See Package Insert for new information on biologics Preventive Vaccine
07/31/2009 Xerese acyclovir/ hydrocortisone Recurrent herpes labialis (cold sores) in 12 years of age and older * Use in adolescents e12 years is supported by evidence from studies in adults with additional safety data in adolescents e12 years * Safety and effectiveness in pediatric patients < 12 years have not been established * Information on clinical studies, and adverse events * New drug Antiviral, topical
07/23/2009 Actonel risedronate Osteogenesis imperfecta * Safety and effectiveness have not been established in pediatric patients * In a 1 year double-blind, placebo controlled study of pediatric patients with osteogenesis imperfecta (OI), treatment with risedronate did not result in a reduction in the risk of fracture * Adverse events similar to those observed in adults except for an increased incidence in vomiting * Information on clinical study Bone density
07/10/2009 Plan B One Step levonorgestrel Emergency contraception - OTC in women 17 years and older; RX for women younger than age 17 years * New single dose 1.5 mg tablet * New dosage regimen Contaceptive
06/18/2009 Nexium esomeprazole Short-term treatment of GERD * Effectiveness was not demonstrated in a randomized, placebo-controlled study in neonates to < 1 year * Information on clinical study, PK/PD parameters Antiulcerative
05/29/2009 Lamictal XR lamotrigine Adjunctive therapy for partial onset seizures in patients e13 years of age * Extended release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients e13 years * Safety and effectiveness of extended release tablets for any use in patients below the age of 13 have not been established * Information on adverse event profile, and clinical studies * New dosage form Anticonvulsant
05/28/2009 Besivance besifloxacin ophthalmic suspension Treatment of bacterial conjunctivitis * Efficacy in pediatric patients 1 year and older has been demonstrated in controlled clinical trials * Safety and effectiveness in infants < 1 year of age have not been established * There is no evidence that the ophthalmic administration of quinolones has any effect on weight bearing joints * Information on AE profile and clinical study * New drug Antibiotic, topical
05/08/2009 Lamictal lamotrigine Adjunctive treatment for partial seizures in pediatric patients 1  24 months * Safety and effectiveness as adjunctive treatment for partial seizures were not demonstrated in a small randomized, double-blind, placebo-controlled, withdrawal study in pediatric patients 1 - 24 months * Immediate release tablets were associated with an increased risk for infectious adverse reactions including bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection (Lamictal 37%, Placebo 5%), and respiratory adverse reactions including nasal congestion, cough, and apnea. (Lamictal 26%, Placebo 5%) Anticonvulsant
05/01/2009 Cetraxal ciprofloxacin otic solution Treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus * Efficacy in pediatric patients 1 year and older has been demonstrated in controlled clinical trials * Safety and effectiveness in infants < 1 year have not been established * There is no evidence that the otic administration of quinolones has any effect on weight bearing joints * Information on AE profile and clinical study * New dosage form Antibiotic, topical
04/30/2009 Axert almotriptan Acute treatment of pediatric migraine in adolescent patients age 12-17 years * Safety and effectiveness established in patients 12  17 years. Efficacy on migraine associated symptoms (nausea, photophobia and phonophobia) was not established. * Safety and effectiveness in pediatric patients < 12 years have not been established * The most common adverse events were dizziness, somnolence, headache, paresthesia, nausea and vomiting. Safety and tolerability similar to adults. * Information on dosing, adverse events, PK parameters, clinical study * Patient population altered Antimigraine
04/30/2009 Creon pancrelipase Exocrine pancreatic insufficiency due to cystic fibrosis or other conditions * Safety and efficacy assessed in a study that included patients 12-18 years * Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase containing the same active ingredient. * High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age * AEs similar to adults * Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce * Information on dosing and clinical study * Not interchangeable with other pancrelipase products * New drug Pancreatic enzyme
04/14/2009 Suprane desflurane Safety study of 2 agents used for maintenance of anesthesia in non-intubated patients * Postmarketing Reports subsection added to the Adverse Events section of labeling, including reports of cardiac disorders. * Postmarketing reports are voluntary; it is not possible to estimate frequency or causality to drug exposure. Anesthetic agent
04/09/2009 Ulesfia Lotion, 5% benzyl alcohol Treatment of head lice * Safety and effectiveness established in pediatric patients 6 months and older * Safety in pediatric patients < 6 months has not been established. * Not recommended in pediatric patients < 6 months due to potential for increased systemic absorption * Neonates are at risk of gasping syndrome due to benzyl alcohol * Adverse events similar to those observed in adults * Information on dosing and administration, warnings and precautions, adverse events, PK parameters, and clinical studies * New drug Pediculocide, topical
03/19/2009 Lexapro escitalopram oxalate Major depressive disorder in adolescents * Safety and effectiveness have been established in adolescents 12 to 17 years for the treatment of MDD. Maintenance efficacy is supported from extrapolation of data from adult studies along with comparisons with racemic citalopram pharmacokinetic parameters in adults and adolescents. * Safety and effectiveness have not been established in pediatric patients <12 years with MDD * Safety and effectiveness have not been established in pediatric patients less than 18 years of age with Generalized Anxiety Disorder * Adverse events generally similar to those observed in adults * Information on dosing, adverse events, PK parameters, and clinical studies * Patient population altered Antidepressant
12/19/2008 Casodex bicalutamide Gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty (testotoxicosis) * Safety and effectiveness have not been established in pediatric patients * Bicalutamide was studied in combination with anastrozole in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of testotoxicosis in patients e2 years * Of the 14 patients exposed to study treatment, 13 had at least one adverse event. Adverse reactions considered possibly related to bicalutamide included gynecomastia (43%), central precocious puberty (14%), breast tenderness (14%), breast pain (7%), asthenia (7%), increased alanine aminotransferase (7%), increased aspartate aminotransferase (7%), and musculoskeletal chest pain (7%). Headache was the only adverse reaction considered possibly related to anastrozole * Information on clinical studies, AEs, and PK parameters Androgen blocker
12/19/2008 Ziagen abacavir HIV infection * Provided new scored tablet for use in pediatric patients weighing >14 kg who can swallow tablets * New dosing regimen Antiviral
12/18/2008 Prezista darunavir Treatment of HIV infection in pediatric patients 6 years and older when co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents * Extended indication from adults to pediatric patients 6 years and older * Safety and effectiveness in pediatric patients 3 to < 6 years of age have not been established * Do not administer in pediatric patients below 3 years of age * Do not administer Prezista/rtv once daily in pediatric patients * Dosing for patients 6 to < 18 years and weighing at least 44 lbs (20 kg) is based on body weight not to exceed adult dose * AE similar to those seen in adults * Information on dose, Aes, PK parameters, lab abnormalities, and clinical study Antiviral
12/17/2008 Epiduo adapalene and benzoyl peroxide Topical treatment of acne vulgaris in patients 12 years of age and older * Safety and effectiveness established in patients 12 years of age and older * Safety and effectiveness in pediatric patients under the age of 12 have not been established * New drug Antiacne, topical
12/11/2008 PegIntron Peginterferon alfa-2b Co-administered with ritonavir to treat chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with interferon alpha * Safety and efficacy established in pediatric patients 317 years of age * Safety and effectiveness in patients < 3 years have not been established. * Dosing for pediatric patients is determined by body surface area for peginterferon alfa-2b and by body weight for ritonavir * An open-label study in patients 3 - 17 years showed weight and height gain of pediatric patients treated with combination therapy lags behind that predicted by population data while on treatment. * Adverse events similar to those observed in adults. Most common pediatric adverse events were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, vomiting * Information on PK parameters, and clinical study * New indication Antiviral
12/05/2008 Arimidex anastrozole Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty * Efficacy has not been demonstrated in clinical studies of anastrozole in the treatment of pubertal gynecomastia in adolescent boys 11-18 years and in the treatment of precocious puberty in girls with McCune-Albright Syndrome 2 to < 10 years * Information on clinical studies, AEs, and PK parameters Estrogen lowering agent
11/14/2008 Neulasta Pefilgrastim Decrease the incidence of infection in pediatric patients with sarcoma * Safety and effectiveness in pediatric patients have not been established * Safety and PK were studied in 37 pediatric patients with sarcoma * Information added to Pediatric Use Hematopoietic
10/28/2008 Prevacid lansoprazole Symptomatic GERD in infants * Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age * AE profile similar to that observed in adults* Information on PK parameters in neonates to < 1 year, and clinical studies Antiulcerative

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

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

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

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

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

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