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US Postmarketing Requirements
Status as of 08-Jul-2013
TRADE NAME (generic
name)
CANCIDAS (caspofungin
acetate)
DUE DATE
STATUS
EXPLANATION OF STATUS
PMR DESCRIPTION
31-Jul-2020
Pending
DULERA (mometasone
furoate (+) formoterol
fumarate)
31-Jul-2012
Submitted
DULERA (mometasone
furoate (+) formoterol
fumarate)
30-Nov-2014
Released
PMR 1658-2 Deferred pediatric trial under PREA to compare the
pharmacokinetics of DULERA with and without a spacer in children 5 to
11 years of age. Final Report Submission
DULERA (mometasone
furoate (+) formoterol
fumarate)
31-Mar-2014
Released
PMR 1658-3 Deferred pediatric trial under PREA to evaluate the effects
of DULERA on the HPA axis in children 5 to 11 years of age. In lieu of
an HPA axis study, you may provide robust data to demonstrate that the
systemic exposure of mometasone from DULERA is comparable or
lower than that from the mometasone dry powder inhaler. Final Report
Submission
DULERA (mometasone
furoate (+) formoterol
fumarate)
31-Aug-2014
Ongoing
PMR 1658-4 Deferred pediatric trial under PREA to evaluate the safety
and efficacy of multiple doses of mometasone MDI in children 5 to 11
years of age with asthma. Final Report Submission
DULERA (mometasone
furoate (+) formoterol
fumarate)
31-Jan-2017
Pending
DULERA (mometasone
furoate (+) formoterol
fumarate)
31-Mar-2017
Pending
DULERA (mometasone
furoate (+) formoterol
fumarate)
30-Jun-2017
Pending
PMR 1658-5 Deferred pediatric trial under PREA to evaluate the safety
and efficacy of DULERA compared to mometasone MDI in children 5 to
11 years of age with asthma. This study will be 12- 26 weeks duration.
Final Report Submission
PMR 1658-6 Deferred pediatric trial under PREA to evaluate the longterm safety of DULERA in children 5 to 11 years of age with asthma.
This study will be 26 weeks duration with a 6 month extension. Final
Report Submission
PMR 1751-1 A randomized, double-blind, 26-week, active-controlled
clinical trial comparing Dulera (mometasone furoate and formoterol
fumarate) Inhalation Aerosol and mometasone furoate to evaluate the
risk of serious asthma outcomes (hospitalizations, intubation, death) in
11,700 adult and adolescent patients 12 years of age and older with
persistent asthma. Final Report Submission
PMR 1 Deferred pediatric study under PREA for the treatment of
candidemia and Candida infections in pediatric patients ages 0 to 3
months. Final Report Submission
PMR 1658-1 Deferred pediatric trial under PREA to compare the
pharmacodynamics of DULERA with and without a spacer in children 5
to 11 years of age. Final Report Submission
Page 1 of 10
US Postmarketing Requirements
Status as of 08-Jul-2013
TRADE NAME (generic
name)
EMEND (aprepitant)
DUE DATE
STATUS
EXPLANATION OF STATUS
PMR DESCRIPTION
31-Oct-2013
Ongoing
One study completed and reported,
two studies ongoing.
EMEND (aprepitant)
31-Oct-2013
Ongoing
One study completed and reported,
two studies ongoing.
EMEND (aprepitant)
31-Jan-2020
Ongoing
One study ongoing and another one
planned.
EMEND for Injection
(fosaprepitant
dimeglumine)
31-Dec-2017
Ongoing
One Study ongoing and another
planned
EMEND for Injection
(fosaprepitant
dimeglumine)
31-May-2014
Ongoing
PMR 1663-1 A PK/PD study to characterize aprepitant PK parameters
following administration of a single dose of intravenous fosaprepitant, in
combination with a 5HT3 antagonist and dexamethasone, in pediatric
cancer patients ages 0 to 17 years undergoing treatment with highly
emetogenic chemotherapy. You must conduct this study with an age
appropriate formulation. Final Report Submission
EMEND for Injection
(fosaprepitant
dimeglumine)
31-Dec-2017
Pending
PMR 1663-2 An adequate, placebo-controlled, double-blind,
randomized, add-on design, superiority study to evaluate the safety and
efficacy of a single dose of intravenous fosaprepitant, in combination
with a 5HT3 antagonist, as compared to standard therapy (a 5HT3
antagonist) in pediatric cancer patients ages 0 to 17 years undergoing
treatment with highly emetogenic chemotherapy. You must conduct this
study with an age appropriate formulation. Final Report Submission
ISENTRESS (raltegravir
potassium)
30-Apr-2013
Submitted
PMR 1395-7 Deferred pediatric studies in patients 2 years to 17 years
of age for the prevention of acute and delayed nausea and vomiting
associated with initial and repeat courses of highly emetogenic cancer
chemotherapy, including high-dose cisplatin until December 31, 2007.
Final Report Submission
PMR 331-1 Deferred pediatric study under PREA for the use of Emend
(aprepitant) in the prevention of nausea and vomiting associated with
initial and repeat courses of moderately emetogenic cancer
chemotherapy in pediatric patients 6 months to less than 17 years of
age. Final Report Submission
PMR 574-1 Deferred pediatric study under PREA for the treatment of
post-operative nausea and vomiting pediatric patients ages 0 to less
than 17 years of age. Final Report Submission
PMR 1450-1 A study in adolescents and younger pediatric patients
receiving emetogenic chemotherapy (HEC or MEC) to evaluate
fosaprepitant PK, safety, and tolerability. Final Report Submission
PMR 1880-1 Conduct a clinical trial to evaluate the effect of coadministration and staggered administration of calcium- or
magnesium/aluminum-containing antacids on the pharmacokinetics of
raltegravir in HIV-infected subjects on a stable raltegravir-containing
regimen. Final Report Submission
Page 2 of 10
US Postmarketing Requirements
Status as of 08-Jul-2013
TRADE NAME (generic
name)
ISENTRESS (raltegravir
potassium)
DUE DATE
STATUS
EXPLANATION OF STATUS
PMR DESCRIPTION
30-Jun-2011
Fulfilled
ISENTRESS (raltegravir
potassium)
30-Jun-2011
Delayed
ISENTRESS Chewable
Tablets (raltegravir
potassium)
31-Jan-2015
Released
PMR 1846-1 Deferred pediatric study under PREA for the treatment of
HIV-1 infection in pediatric subjects from ages 0 to <4 weeks of age. The
study will determine the safety, antiviral activity and pharmacokinetic
profile of raltegravir in neonates. The antiviral activity will be based on
the results of virologic response over at least 24 weeks of dosing and
safety will be monitored for a minimum of 24 weeks. Final Report
Submission
ISENTRESS Chewable
Tablets (raltegravir
potassium)
31-Jan-2015
Pending
PMR 1881-1 Deferred pediatric study under PREA to evaluate the safety
and pharmacokinetics of raltegravir in HIV-exposed neonates (born to
HIV-infected mothers). This multiple-dose pharmacokinetic and safety
study will evaluate raltegravir in addition to the standard of care in HIVexposed neonates from ages 0 to 4-6 weeks. HIV-exposed neonates will
have safety assessments, on or off treatment (as appropriate), for a
minimum of 24 weeks after start of raltegravir therapy. Final Report
Submission
JANUMET (sitagliptin
phosphate (+) metformin
hydrochloride)
15-Jun-2011
Fulfilled
Per FDA letter dated 02/01/2013, this PMR 1603 A 3-month pancreatic safety study in a diabetic rodent model
PMR has been fulfilled.
treated with sitagliptin. Final Report Submission
PMR 582-2 Deferred pediatric study under PREA for the treatment of
HIV-1 infection in pediatric subjects from 2 to 18 years of age. This study
will determine raltegravir exposure (pharmacokinetic profile) followed by
24 weeks of dosing. Efficacy will be based on viral load reduction
through 24 weeks of dosing and safety will be monitored for a minimum
of 24 weeks to support raltegravir dose selection, safety, and efficacy in
this population. Final Report Submission
FDA acknowledged new target date
of 1/5/2015 for study report.
PMR 582-3 Deferred pediatric study under PREA for the treatment of
HIV-1 infection in pediatric subjects from 4 weeks to 2 years of age. This
study will determine raltegravir exposure (pharmacokinetic profile)
followed by 24 weeks of dosing. Efficacy will be based on viral load
reduction through 24 weeks of dosing and safety will be monitored for a
minimum of 24 weeks to support raltegravir dose selection, safety, and
efficacy in this population. Final Report Submission
Page 3 of 10
US Postmarketing Requirements
Status as of 08-Jul-2013
TRADE NAME (generic
name)
JANUMET (sitagliptin
phosphate (+) metformin
hydrochloride)
DUE DATE
STATUS
EXPLANATION OF STATUS
25-Apr-2018
Ongoing
JANUMET XR (sitagliptin
phosphate (+) metformin
hydrochloride)
01-Jun-2014
Pending
PMR 1802-1 A pharmacokinetic study of JANUMET XR in pediatric
patients 10 through17 years of age (inclusive) with type 2 diabetes
mellitus. Final Report Submission
JANUMET XR (sitagliptin
phosphate (+) metformin
hydrochloride)
01-Mar-2017
Released Released and replaced with new
PMR 1802-3
PMR 1802-2 A 54-week, randomized, double-blind placebo-controlled
trial to evaluate the efficacy and safety of JANUMET XR vs. metformin in
pediatric patients who are inadequately controlled on diet and exercise.
You must also evaluate whether pediatric patients can safely swallow
JANUMET XR over the course of the trial. Final Report Submission
JANUMET XR (sitagliptin
phosphate (+) metformin
hydrochloride)
01-Mar-2017
Pending
PMR 1802-3 A 54-week, randomized, double-blind placebo-controlled
trial to evaluate the efficacy and safety of JANUMET XR versus
metformin extented-release in pediatric patients who are inadequately
controlled on metformin immediate release. You must also evaluate
whether pediatric patients can safely swallow JANUMET XR over the
course of the trial. Final Report Submission
JANUVIA (sitagliptin
phosphate)
JANUVIA (sitagliptin
phosphate)
15-Jun-2011
Fulfilled
25-Apr-2018
Ongoing
JUVISYNC (sitagliptin
phosphate (+)
simvastatin)
31-Jul-2015
Pending
NOXAFIL (posaconazole)
15-Sep-2011
NOXAFIL (posaconazole)
20-Oct-2011
One study completed and reported,
one study ongoing.
PMR DESCRIPTION
PMR 856-1, Deferred pediatric study under PREA for the treatment of
type 2 diabetes in pediatric patients ages 11 to 16, inclusive. Final
Report Submission
Per FDA letter dated 02/01/2013, this
PMR has been fulfilled.
One study completed and reported,
one study pending.
PMR 1602 A 3-month pancreatic safety study in a diabetic rodent model
treated with sitagliptin. Final Report Submission
PMR 224-1, Deferred pediatric study under PREA for the treatment of
type 2 diabetes in pediatric patients ages 11 to 16, inclusive. Final
Report Submission
PMR 1826-1 A randomized, double-blind, active-controlled clinical trial
to study the effect of sitagliptin and simvastatin fixed-dose combination
versus sitagliptin on glycemic control in type 2 diabetic patients on
background metformin therapy. Final Report Submission
Delayed
FDA acknowledged new target date
of 4/15/2016 for study report.
PMR 28-3 Deferred pediatric study under PREA for the prophylaxis of
invasive Aspergillis and Candida infections in patients, who are at risk of
developing these infections in pediatric patients two years to twelve
years of age. Final Report Submission
Delayed
FDA acknowledged new target date
of 7/1/2017 for study report.
PMR 864-1 Deferred pediatric study under PREA for the treatment of
oropharyngeal candidiasis in pediatric patients ages zero to sixteen
years of age. Final Report Submission
Page 4 of 10
US Postmarketing Requirements
Status as of 08-Jul-2013
TRADE NAME (generic
name)
PEGINTRON
(peginterferon alfa-2b)
DUE DATE
STATUS
EXPLANATION OF STATUS
PMR DESCRIPTION
31-Mar-2014
Ongoing
PMR Completion of the 5-year follow-up observational study of subjects
enrolled in Part 2 of the pediatric study P02538, to assess long-term or
delayed toxicity including the effect of PegIntron on height and weight
and the durability of treatment response. Submit data for at least 50
pediatric subjects completing the 5 year follow-up. Final Report
Submission
SAPHRIS (asenapine
maleate)
01-Dec-2016
Ongoing
SAPHRIS (asenapine
maleate)
01-Dec-2016
Ongoing
PMR 1496-1 A deferred pediatric study under PREA for the treatment of
schizophrenia in pediatric patients ages 13 to 17 years. A study to obtain
pharmacokinetic data and provide information pertinent to dosing of
asenapine sublingual tablets in the relevant pediatric population. Final
Report Submission
PMR 1496-2 A deferred pediatric study under PREA for the treatment of
schizophrenia in pediatric patients ages 13 to 17 years. A study of the
efficacy and safety of asenapine sublingual tablets in the relevant
pediatric population. Final Report Submission
SAPHRIS (asenapine
maleate)
01-Dec-2016
Ongoing
PMR 1496-3 A deferred pediatric study under PREA for the treatment of
acute manic or mixed episodes associated with Bipolar I Disorder ages
10 to 17 years. A study to obtain pharmacokinetic data and provide
information pertinent to dosing of asenapine sublingual tablets in the
relevant pediatric population. Final Report Submission
SAPHRIS (asenapine
maleate)
01-Dec-2016
Ongoing
SINGULAIR (montelukast
sodium)
31-Dec-2009
Fulfilled
SINGULAIR (montelukast
sodium)
31-Dec-2009
Fulfilled
SINGULAIR (montelukast
sodium)
31-Dec-2009
Fulfilled
PMR 1496-4 A deferred pediatric study under PREA for the treatment of
acute manic or mixed episodes associated with Bipolar I Disorder ages
10 to 17 years. A study of the efficacy and safety of asenapine
sublingual tablets in the relevant pediatric population. Final Report
Submission
PMR Deferred pediatric study under PREA for the prevention of exerciseinduced bronchoconstriction in pediatric patients ages 4 - 14 years of
age. NDA 20-829. Final Report Submission
PMR Deferred pediatric study under PREA for the prevention of exerciseinduced bronchoconstriction in pediatric patients ages 4 - 14 years of
age. NDA 20-830. Final Report Submission
PMR Deferred pediatric study under PREA for the prevention of exerciseinduced bronchoconstriction in pediatric patients ages 4 - 14 years of
age. NDA 21-409. Final Report Submission
Page 5 of 10
US Postmarketing Requirements
Status as of 08-Jul-2013
TRADE NAME (generic
name)
SYLATRON
(peginterferon alfa-2b)
DUE DATE
STATUS
EXPLANATION OF STATUS
PMR DESCRIPTION
30-Dec-2011
Fulfilled
PMR #1 To develop a validated, sensitive, and accurate assay for the
detection of neutralizing antibodies to peginterferon alfa-2b, including
procedures for accurate detection of neutralizing antibodies to
peginterferon alfa-2b in the presence of peginterferon alfa-2b levels that
are expected to be present in the serum or plasma at the time of patient
sampling. In the event such an assay cannot be developed, evidence of
due diligence in attempting to develop the assay will be provided. Final
Report Submission
SYLATRON
(peginterferon alfa-2b)
15-Jul-2020
Ongoing
PMR #2 To conduct a randomized, multicenter, observation-controlled
trial of peginterferon alfa-2b as adjuvant therapy in 1200 patients with
ulcerated primary cutaneous melanoma with negative sentinel lymph
node biopsy (T1b-T4bN0M0) randomized 1:1 to peginterferon alfa-2b
3.0 mcg/kg SC administered weekly for 24 months or observation alone
for 24 months. The trial will characterize toxicity of treatment, specifically
debilitating fatigue, depression, and anorexia, and evaluate relapse-free
survival (RFS). Secondary endpoints will include overall survival. The
trial will be powered to detect an increase in RFS rate by 6.8% at 2
years, by 9.4% at 5 years, and by 10% at 10 years. The trial will be
powered to detect a hazard ratio of 0.7 for overall survival. The trial
design and statistical analysis plan must adequately address the
comments provided to you in our December 10, 2010, letter to IND 7194
regarding proposed trial 18081. Final Report Submission
SYLATRON
(peginterferon alfa-2b)
31-May-2014
Pending
PMR #3 To conduct a clinical trial that will assess the effect of
peginterferon alfa-2b on the QT/QTc interval. This QT assessment must
be performed in an adequate number of subjects receiving the highest
clinical dose approved and at the steady state maximum therapeutic
exposure that is anticipated in patients with melanoma to ensure that
changes of 20 ms in QTc interval can be excluded. ECG with timematched PK samples will be collected at the anticipated steady state
concentration and across the entire dosing interval at steady state.
ECGs will be collected in replicates and centrally read. Statistical
analyses will include central tendency analysis, concentration-QT
analysis and categorical analysis. Final Report Submission
Page 6 of 10
US Postmarketing Requirements
Status as of 08-Jul-2013
TRADE NAME (generic
name)
SYLATRON
(peginterferon alfa-2b)
DUE DATE
STATUS
EXPLANATION OF STATUS
PMR DESCRIPTION
30-Apr-2012
Fulfilled
PMR #4 To conduct an assessment of anti-drug antibody (ADA) and
neutralizing ADA responses to peginterferon alfa-2b with validated
assays capable of sensitively detecting ADA responses in the presence
of peginterferon alfa-2b levels that are expected to be present at the
time of patient sampling. ADA responses will be evaluated in all
available samples from Trial EORTC 18991. Samples tested positive for
binding ADA will be evaluated for neutralizing ADA responses. The final
report will include information on the level of peginterferon alfa-2b in
each patient's test sample at each sampling time point. Final Report
Submission
SYLATRON
(peginterferon alfa-2b)
31-May-2014
Pending
PMR #5 To conduct a drug interaction trial in 24 healthy subjects
receiving subcutaneous peginterferon alfa-2b 6 mcg/kg once weekly for
four weeks with probe substrates for multiple cytochrome P450 enzymes
administered before the first dose and after the last dose of
peginterferon alfa-2b. Pharmacokinetic blood and urine samples will be
collected after the administration of the probe substrates and
peginterferon alfa-2b (up to 168 hours) to measure enzyme activities
and peginterferon alfa-2b systemic exposure. Final Report Submission
SYLATRON
(peginterferon alfa-2b)
31-Aug-2013
Ongoing
PMR #6 To conduct a dedicated clinical trial assessing the safety and
pharmacokinetics (PK) of peginterferon alfa-2b in accordance with the
FDA Guidance for Industry: Pharmacokinetics in Patients with Impaired
Renal Function - Study Design, Data Analysis and Impact on Dosing and
Labeling. The renal function subgroups should have similar demographic
characteristics with respect to age, gender and weight. The number of
patients enrolled in the trial should be sufficient to detect clinically
important PK differences that would warrant dosage adjustment
recommendation. The frequency and duration of blood sampling should
be sufficient to accurately estimate relevant PK parameters for the
parent drug. A data analysis plan should be included in the final protocol
submitted to FDA. Final Report Submission
Page 7 of 10
US Postmarketing Requirements
Status as of 08-Jul-2013
TRADE NAME (generic
name)
VICTRELIS (boceprevir)
DUE DATE
STATUS
EXPLANATION OF STATUS
PMR DESCRIPTION
31-May-2013
Released
PMR 1767-01 Conduct a single-dose pharmacokinetics study of
boceprevir in treatment naïve pediatric subjects 3 through 17 years of
age to determine weight-based dosing for children that will result in
exposures similar to those observed in adults. Final Report Submission.
VICTRELIS (boceprevir)
31-Jul-2012
Fulfilled
VICTRELIS (boceprevir)
31-Oct-2015
Released
PMR 1767-10 Conduct an in vivo drug-drug interaction trial between
boceprevir and a selective serotonin reuptake inhibitor (SSRI) (e.g.
escitalopram). Final Report Submission
PMR 1767-2 Conduct a trial to evaluate safety and treatment response
of boceprevir in combination with pegylated interferon and ribavirin as
measured by sustained virologic response (SVR) in pediatric subjects 3
through 17 years of age, including previously untreated subjects and
those who have failed a prior course of pegylated interferon and ribavirin
therapy. This trial should include at least 5 years follow-up of pediatric
subjects to characterize long-term safety of boceprevir, including growth
assessment and sexual maturation in pediatric subjects, to determine
the durability of response and to characterize boceprevir resistanceassociated substitutions. Final Report Submission
VICTRELIS (boceprevir)
31-Jul-2012
Fulfilled
PMR 1767-3 Conduct a study to assess the impact of boceprevir
treatment-emergent NS3 amino acid substitutions (those that have been
observed but not characterized phenotypically) on the anti-HCV activity
of boceprevir in the HCV replicon system. Potentially novel resistanceassociated substitutions should also be evaluated. The HCV replicon
genotype/subtype background used should be consistent with the
background in which the specific substitutions have been observed in
treated patients. Evaluations should include HCV replicons with
previously characterized resistance-associated substitutions spanning
the range of susceptibilities as reference standards. Specific examples
of substitutions to be assessed include the following: a. D168N, with and
without linked R155T, genotype 1a replicon b. V107I, with and without
linked V36M+R155K, genotype 1a replicon c. P146S, with and without
linked V36M+R155K, genotype 1a replicon d. I170V, genotype 1a
replicon e. V36M, R155K and V36M+R155K, genotype 1a replicon Final
Report Submission
Page 8 of 10
US Postmarketing Requirements
Status as of 08-Jul-2013
TRADE NAME (generic
name)
VICTRELIS (boceprevir)
DUE DATE
STATUS
EXPLANATION OF STATUS
PMR DESCRIPTION
30-Apr-2013
Fulfilled
PMR 1767-4 Conduct pooled analyses to characterize the impact of
detectable baseline boceprevir resistance-associated polymorphisms on
the efficacy of boceprevir + Peg-IFNa/RBV treatment regimens among
subjects who (1) respond relatively poorly to the Peg-IFNalpha/RBV 4week lead-in (e.g., <1 log10 IU/mL decline, greater than or equal to 1
log10 IU/mL to <2 log10 IU/mL decline, etc.), or (2) have an unfavorable
IL28B genotype (if data are available). These pooled analyses should be
conducted using data from the following completed and currently
ongoing boceprevir clinical trials: P03523, P05216, P05101, P05411,
P05685, and P06086. These analyses should be completed, and a study
report submitted, within 9 months of collection of SVR outcome data
from these clinical trials. Final Report Submission
VICTRELIS (boceprevir)
31-Jul-2012
Fulfilled
PMR 1767-5 Conduct a study to analyze NS3/4A protease cleavage
sites for the presence of boceprevir treatment-emergent substitutions for
a selected subset of subjects (n~10) representative of the virologic
failure responses and NS3 protease resistance patterns observed in
Phase 3 trials. An additional subset of subjects (n~10) who experienced
virologic failure, but for whom no clear resistance-associated
substitutions in NS3/4A were detected, should also be analyzed for the
presence of boceprevir treatment-emergent substitutions in NS3/4A
protease cleavage sites. Final Report Submission
VICTRELIS (boceprevir)
31-Jul-2012
Fulfilled
PMR 1767-6 Report results from ongoing clinical trial P05063 regarding
the long-term persistence of amino acid substitutions that emerged in
boceprevir-treated subjects from the following Phase 2 and Phase 3
trials conducted to date: P03523, P03659, P05216 and P05101. For
long-term, follow-up analyses of subjects from the Phase 3 trials
(P05216 and P05101), if available, the same assay/vendor used initially
to identify the treatment-emergent substitutions should continue to be
used to monitor the persistence of the substitutions in the follow-up
period. The persistence of detectable amino acid substitutions should be
assessed for a treatment-free follow up period of approximately 2 years.
Final Report Submission
Page 9 of 10
US Postmarketing Requirements
Status as of 08-Jul-2013
TRADE NAME (generic
name)
VICTRELIS (boceprevir)
DUE DATE
STATUS
EXPLANATION OF STATUS
PMR DESCRIPTION
31-Jul-2012
Fulfilled
PMR 1767-7 Conduct an in vivo drug-drug interaction trial between
boceprevir and an oral contraceptive containing a progesterone
component other than drospirenone. Final Report Submission
VICTRELIS (boceprevir)
31-Mar-2012
Fulfilled
VICTRELIS (boceprevir)
30-Apr-2012
Fulfilled
VICTRELIS (boceprevir)
31-Aug-2016
Ongoing
PMR 1767-8 Conduct an in vivo drug-drug interaction trial between
boceprevir and methadone. Final Report Submission
PMR 1767-9 Conduct an in vivo drug-drug interaction trial between
boceprevir and a sensitive substrate of p-glycoprotein (e.g. digoxin).
Final Report Submission
PMR 2034-1 Evaluate single-dose pharmacokinetics (PK) of boceprevir
in treatment-naïve pediatric subjects 3 through 17 years of age to
determine weight-based dosing for children that will result in exposures
similar to those found to be safe and effective in adults. Using dose(s)
selected based on the PK evaluation and agreed upon with the FDA,
evaluate safety and treatment response of boceprevir in combination
with pegylated interferon and ribavirin. Treatment response should be
measured by sustained virologic response (SVR) in all pediatric
subjects including previously untreated subjects and those who have
failed a prior course of pegylated interferon and ribavirin therapy. Final
Report Submission
VICTRELIS (boceprevir)
31-Aug-2021
Ongoing
PMR 2034-2 Collect long-term safety data for subjects enrolled in the
pediatric boceprevir safety and treatment trial. Data collected should
include at least 5 years of follow-up in order to characterize the longterm safety of boceprevir in pediatric patients, including growth
assessment, sexual maturation and characterization of boceprevir
resistance-associated substitutions in viral isolates from subjects failing
therapy. Long-term Final Report Submission
ZETIA (ezetimibe)
31-Dec-2019
Released
PMR 1806-1 Pediatric Plan in Adolescents at High Risk for
Cardiovascular Disease with Primary Hypercholesterolemia. Final
Report Submission
Page 10 of 10