• New dosage form:  ointment that differed from already approved ointment with pediatric clinical trials to demonstrate equivalence

• New dosage form
• adolescents 12-17 years of age included in clinical safety studies.
• dosing regimen established
• waived in children < 12 years of age because rarely seen in that population

• New indication
• effectiveness extrapolated from studies in patients 15 years of age and older and supported  with one pediatric safety  trial in patients 2-14 years of age

Treatment of Attention-Deficit Hyperactivity Disorder in children 6 years of age and older

Treatment of narcolepsy in children 6 years of age and older

• New dosage form
• bioequivalence studies in adults

• New active ingredient
• safety and effectiveness extrapolated from existing clinical database
• safety and effectiveness not established in patients < 12 years of age
• partial waiver 0-12 years of age because general anesthesia is preferred in that population

Treatment of acute otitis media in patients with tympanostomy tubes (inner ear infection) in children 6 months of age and older

Treatment of acute otitis externa (outer ear infection) in children 6 months of age and older

• New dosage form
• over 700 pediatric patients in safety and effectiveness  studies to support both indications
• pediatric dosing information added

• New dosing regimen
• dosing change from 2 times daily to 1 time daily for 7 days based on effectiveness and safety studies that included pediatric patients

• Pediatric submission
• extended indication down from 18 years of age to 12 years of age
• effectiveness extrapolated from adult studies
• safety study in patients 12-17 years of age

• New drug
• based on effectiveness and safety studies that included children down to 10 years of age
• partial waiver for children < 3 years of age because the condition does not exist in the age group

• New drug
• safety and effectiveness established in clinical trials involving adolescent patients
• studies in patients less than 12 years of age waived because there are too few children with the disease to study

• New indication
• effectiveness extrapolated from adult sinusitis studies and from pediatric acute otitis media studies
• clinical studies conducted in pediatric patients 3 years to 16 years of age  to determine PK and safety for oral suspension
• safety and effectiveness in patients under 6 months of age have not been established
• side effects seen in pediatric patients were comparable to those seen in adults, with different incidence rates for the dosage regimens recommended in pediatric patients
• dosing regimen established
• partial waiver < 6 months of age because too few patients to study

• New dosage form
• effectiveness extrapolated from adult studies
• bioequivalence studies in healthy adults
• PK and safety studies in children 6 to 12 years of age

• New active ingredient
• approval based on extrapolation of safety and effectiveness in adult patients
• one PK study with  information down to 5 years of age
• waived studies in birth to 10 years because there are too few children to study.

• New dosage form
• 505(b)(2) approved with no pediatric information
• age range based on monograph
• do not use in children under 12 years of age
• studies waived in children < 12 years of age due to safety concerns

• New dosage form; new route of administration
• 505(b)(2) with clinical studies
• safety and effectiveness established in studies of pediatric patients 5-18 years of age
• PK study in pediatric patients 6-15 years of agedosing regimen established in clinical trials
• studies in patients 0-5 years of age deferred

• New route of administration
• safety and effectiveness established from studies in patients 3-11 years of age
• dosing information added for external insulin pumps

• New dosage form; new dosing regimen
• approval and age range based on monograph for antitussives and antihistamine
• no clinical studies submitted
• studies in children < 6 years of age deferred

• New indication
• approval based on monograph and previous studies for other indication
• no new studies submitted
• studies in children birth - 12 years of age waived

• New dosage form
• effectiveness extrapolated from adult studies
• safety established based on two studies that included pediatric patients 12-17 years of age
• not indicated for children under 12 years of age based on safety risk of aspiration
• studies waived in children under 12 years of age due to safety concerns

• New drug
• approved for use in all populations based on information from clinical trials in the literature

• New indication
• no new pediatric studies
• effectiveness extrapolated from adult studies for Augmentin XR for ABS and from studies in pediatric patients with otitis media and by similar pharmacokinetics in pediatric patients

• New indication
• based on clinical trials that included patients down to 3 years of age.

• New active ingredient; new dosing regimen
• two safety and effectiveness studies conducted in patients 12 years of age and older
• PK study
• studies waived in children < 12 years of age

• New active ingredient
• extended indication for use in children down from 6 years of age
• pediatric patients have a lower exposure to the drug than adults
• population PK model developed from patients down to 4 years of age
• effectiveness and safety established from studies in adults, adolescents (12 years of age and older) and children ages 4-11 years of age with asthma.
• deferred studies in patients < 4 years of age

• New dosage form
• no new clinical studies submitted
• PK data
• dosing information for new dosage form (to decrease esophagitis seen from capsules)

• New indication
• supported by extrapolating safety and effectiveness from an adequate and well-controlled adult study and additional data from pediatric PK studies
• studies waived for children < 3 months of age

• New dosage form
• should not be used in children under 6 years of age
• effectiveness in patients age 6 years of age and older was established in clinical studies
• PK studies also conducted
• long-term effects in children have not been established

• New indication
• effectiveness established in studies of patients down to 6 years of age
• use in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials
• provides information regarding treatment-emergent decrease in serum bicarbonate and adverse events
• some patients in the study discontinued therapy due to adverse events; however, adverse events associated with discontinuing therapy included difficulty with concentration/attention
• studies waived in children 0-2 years of age; deferred in children 2-10 years of age

• New indication
• effectiveness was extrapolated from a rhinitis study in patients 15 years of age and older safety and PK in patients as young as 6 months is supported by extrapolation from safety data obtained from studies in patients 6 to 23 months of age with asthma
• studies waived in children < 6 months of age

• New dosage form; new dosing regimen 
• no new clinical studies
• bioequivalence study in adults compared the current OTC drug (Imodium caplet) and this drug
• studies waived in children 0-2 years of age

• New indication
• effectiveness established in studies of patients 2 years of age and older

• New indication (not approved in pediatric patients)
• provided additional safety data for changes in weight, height, and appetite occurring in pediatric patient
• information based on a clinical study of patients with SAD

• New dosing regimen
• approval based on two safety and effectiveness studies in patients down to 12 years of age
• Not an appropriate dosage form for use in pediatric patients below 12 years of age.
• studies waived in children < 12 years of age

• New indication (expands use from previously approved bronchospasm with reversible obstructive airway disease)
• effectiveness based on study in adults and adolescents
• safety and effectiveness in pediatric patients below 12 years of age have not been established

• New active ingredient
• indicated for use in immunocompetent  children
• presence of candidal infection should be established by microscopic evaluation prior to initiating treatment
• effectiveness based on three clinical studies in infants and toddlers
• safety when used for more than 7 days is not known

• New indication
• use in pediatric patients younger than 12 years of age is not recommended
•   effectiveness extrapolated from adult studies
• safety in patients 12 to 17 years of age was similar to that observed in adults
• . information provided on HPA axis suppression from safety studies  with Vanos Cream in 4 cohorts of pediatric patients (3 months - 18 years of age) with atopic dermatitis
• studies waived in children 0-11 years  of age

• New indication
• safety and effectiveness for prophylaxis based on 4 clinical studies in patients 5-16 years of age
• no differences in safety and effectiveness were observed between pediatric and adult subjects.
• dosing information provided
• studies waived in children <5 years of age

• New indication
• indicated for use in pediatric patients with open epiphyses
• effectiveness and safety based on studies in pediatric patients

• New dosage form
• only used to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris
• safety and effectiveness established from  studies in patients 12 years of age and older
• safety and effectiveness in pediatric patients below 12 years of age has not been established
• studies waived in children 0-11 years of age

• New active ingredient
• studies failed to show effectiveness over placebo in reducing the pain associated with venipuncture in pediatric patients 5-17 years of age

Prevention of sunburn and protection from UVA and UVB rays in children 6 months of age and older

OTC

• New active ingredient
• effectiveness extrapolated from adult studies
• safety studies included pediatric patients 6 months of age and older
• age range based on monograph
• deferred studies in children < 6 months of age

• New active ingredient
• effectiveness and safety in patients 12 years of age and older established in studies up to 12 months long
• PK studies in patients 6-11 years of age
• effectiveness in patients 6 to < 12 years of age has not been established
• overall safety profile in patients 6 to < 12 years of age was similar to that observed in patients 12 years of age and older
• studies waived in children 0-6 years of age; deferred in children 6-12 years of age

• New indication
• safety of manual injection in pediatric patients is supported by reported clinical experience with IV infusion and flushsafety and effectiveness of Sodium Chloride Injection, USP 0.9% administered by power injection in pediatric patients have not been established
• administration to pediatric patients by power injection is not recommended
• to minimize the risk of fluid overload, the smallest dose necessary for manually flushing contrast agent through the vascular access line should be used
• manual injection to pediatric patients should take into account the patient's weight, fluid status, and concomitant medical conditions to determine if use is appropriate

• New dosage form
• effectiveness established from studies in patients 12 years of age and older
• safety and effectiveness in pediatric patients below 12 years of age have not been establishedstudies waived in children 0-12 years of age

• New drug
• information on PK and safety studies in patients 13-17 years of agesafety profile in patients 8-17 years of age similar to adults
• safety and effectiveness in patients below 13 years of age have not been established
• additional information on pharmacokinetics provided in patients down to 8 years of age
• studies deferred in children 0-12 years of age

• New dosage form
• effectiveness established from studies in 581 pediatric patients 3 months to 17 years of age
• effect on HPA axis function was investigated in pediatric patients 6 months to 17 years of age in one study of 75 patients
• safety has not been evaluated in patients below 3 months of age
• use for the minimum amount of time necessary due to the potential to suppress HPA axis
• treatment should not exceed 4 consecutive weeks

• New indication
• effectiveness established in study with patients down to 2 years of age
• revised boxed warning to remove restrictions on use in pediatric patients

• New active ingredient
• effectiveness based on determination that permeability of skin in children > 2 months of age is essentially that of adult skin
• studies waived in children under 2 months of age for safety reasons and includes the following statement in the label:  Do not use in children under 2 months of age due to excessive skin irritation and transient hypothyroidism.

UV Protective Suncare (avobenzone; ecamsule; octocrylene; titanium)#

Capital Soleil 20 (avobenzone; ecamsule; octocrylene; titanium)#

Anthelios 20 (avobenzone; ecamsule; octocrylene; titanium)#

UV Expert 20 (avobenzone; ecamsule; octocrylene; titanium)#

L'Oreal

label

• New active ingredient
• no clinical studies submitted to support
• age range based on monograph
• studies deferred in children under 6 months of age

• New indication
• effectiveness and safety established based on two 8 week studies in patients 5-16 years of age and one long-term study of 4-6 months
• studies waived in children under 2 years of age due to difficulty to diagnose and treat this population

• New dosage form
• contraindicated in infants, small children, or any child who may be unable to swallow a capsule.
• dosing information provided
• information to monitor disease provided
• No clinical studies submitted

• New indication
• No new studies submitted

• New dosage form
• effectiveness established from two studies in patients 3 months to 18 years of age
• not recommended for use in patients under 3 months of age
• treatment should not exceed 4 consecutive weeks
• HPA axis suppression studied in patients 6 months of age to 6 years of age

• New indication
• effectiveness established from one 2-year study for SHOX in 52 pediatric patients
• information on adverse events provided
• dosing information provided

• New active ingredient
• effectiveness and safety based on two studies in  patients 12 years of age and older

Vyvanse Capsules
(lisdexamfetamine)

New River

label

• New active ingredient
• effectiveness established in two studies of patients 6-12 years of age
• long-term effectiveness of more than 4 weeks has not been established
• studies waived in children 0-5 years of age and deferred in children 13-17 years of age

Keppra Tablets
(levetiracetam*);
Keppra Oral Solution
(levetiracetam*)

UCB

label

• New indication
• safety and effectiveness established in study that included patients down to 4 years of age
• pediatric dosing information added
• studies waived in children 1 month to 2 years of age and deferred in children 2-6 years of age

Altabax Ointment 1% (retapamulin)

GlaxoSmithKline

label

• New active ingredient
• safety and effectiveness established in studies that included 588 pediatric patients from 9 months of age to 17 years of age
• studies waived in children 0-2 months of age and deferred in children 2-9 months of age

Azasite Ophthalmic Solution 1%
(azithromycin)

InSite Vision

label

• New dosage form
• effectiveness and safety were established in controlled clinical trials including patients down to 1 years of age
• dosing information provided

• New dosage form
• effectiveness established in one study of 284 patients from 3 months to 18 years of age
• information provided on HPA axis suppression from one safety study with Locoid Lotion of 84 pediatric patients from 3 months to 18 years of age with moderate to severe atopic dermatitis affecting at least 25% of body surface area
• studies waived in children < 3 months of age

• New dosage form
• should not be used in children under 12 years of age
• effectiveness was established in clinical studies that included pediatric patients 12 years of age and older
• short-term and long-term safety were established in clinical studies that included pediatric patients 12 years of age and older
• studies waived in children 0-4 years of age and deferred in children 5-11 years of age

• New indication
• effectiveness and safety were established in clinical studies of children 3-14 years of age
• the most common adverse events reflect common infections of childhood
• Cardiac abnormalities are part of Noonan Syndrome; therefore, it is not unexpected that cardiac disorders were the second most commonly reported adverse event.  There was no evidence of somatropin-induced ventricular hypertrophy or exacerbation of preexisting ventricular hypertrophy during the study.
• dosing information provided

• New dosage form effectiveness and safety were established in a clinical study that included 44 patients from 12-17 years of age studies waived in children 0-12 years of age

• New dosage form
• effectiveness and safety were established in two clinical studies of pediatric patients 2-18 years of age
• adverse event profile is similar to that of adults with the exception of vomiting, which, regardless of causality, occurred more frequently among pediatric patients
• dosing information provided
• studies waived in children 0-1 month of age and deferred in children 1 month - 2 years of age

Atralin Gel, 0.05% (tretinoin)

Coria Laboratories, Ltd.

Label

• New dosing regimen
• extended indication down from 12 years to 10 years of age.
• safety and effectiveness in children below the age of 10 have not been established
• efficacy and safety were evaluated in clinical studies of children 10-16 years of age
• comparable safety and efficacy was observed between pediatric and adult subjects
• waiver younger patients because of too few patients

• New dosage form; new route of administration
• safety and effectiveness in pediatric patients below the age of 3 years have not been established
• two clinical studies evaluated efficacy in children 3 – 18 years of age
• waiver for studies in children less than 3 years of age because of inadequate surface area to operate the device correctly, and self assessment pain measurements in pre-verbal children is difficult to achieve

• New drug
• safety and effectiveness has been established in pediatric patients based on known metabolism of ammonia, radiation dosimetry in the pediatric population, and clinical studies in adults
• Dosing regimen established down to 1 year of age
• PK have not been studied in pediatric patients

• New indication
• pediatric dosing information provided
• two clinical studies evaluated safety and efficacy in children
• additional safety information regarding pediatric patients with Turner syndrome described an increased risk of ear and hearing disorders (otitis media) as well as need for close monitoring for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension)

• New active ingredient
• safety and effectiveness supported by evidence from clinical studies in adults with additional data from a study in children with glaucoma ages 2 – 7  years old
• not recommended for use in children under the age of 2 years due to safety concerns based on reports of apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence in infants
• safety and effectiveness have not been studied in children below the age of two years

• New dosing regimen
• dosing and administration information provided for children
• Use of a lower strength tablet in a twice daily dosing regimen for pediatric patients weighing greater than 15 kg

• New indication
• indication extended down to 6 years of age
• pediatric dosing information provided
• two clinical studies evaluated safety in children 6 to 11 years of age and the overall incidence of adverse events was comparable to those treated with placebo
• efficacy in children 2 to 5 years of age was not established in clinical trials conducted in this age group.
• waiver of studies in children ages 0 to less than 2 years of age for SAR because of local and systemic safety concerns as well as lack of disease and/or diagnosis difficulties in children

• New indication
• efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations
• adverse effects of corticosteroids in pediatric patients are similar to those in adults

• New indication
• extended age range down to 3 months
• effectiveness and safety are not established in children less than 3 months old
• safety was evaluated in two pediatric clinical studies (including facial use)
• pediatric dosing and administration information provided
• studies waived in children under 3 months of age due to safety concerns of adrenal suppression

• New dosage form
• not indicated for children under the age of 12 years
• five clinical studies evaluated safety in children 12 years of age and older
• safety and effectiveness have not been established in children under 12 years of age
• waiver of studies in children 0 to less than 6 months of age due to too few patients with the disease

• New dosage form
• safety and effectiveness in pediatric patients younger than 12 years have not been established
• one clinical study evaluated safety and effectiveness in pediatric patients 12 years of age and older with no significant differences in treatment response or adverse reactions between adults and children
• a prospective study of 51 children suggested that overdosages of less than 250 mg/kg are not associated with significant clinical symptoms and do not require gastric emptying
• waiver of studies in children ages 0 to less than two years because too few children have the disease

Asmanex Twisthaler 110mcg (mometasone furoate inhalation powder)

Schering Corporation

[Label not available]

• New dosage form
• not indicated for relief of acute bronchospasm or in children less than 4 years of age
• clinical studies, including 52 week safety trial conducted in children 4 – 11 years of age
• pediatric dosing information provided
• child may not get the most benefit for 1 to 2 weeks or longer after starting treatment