Janssen Pharmaceutical Companies
Product
Due Date
Status
Description of Commitment
or Requirement
U.S. Post-Marketing
Requirements
and Commitments
October 2014
1
Product
Due Date
Status
Description of Commitment or Requirement
DOXIL® (doxorubicin HCl
liposome injection)
31-Dec-2011
Delayed
Continue follow-up of safety and efficacy on clinical study MMY-3001; submit the
final survival data analysis as well as an updated clinical study report after at least
80% of events have occurred.
DURAGESIC® (fentanyl
transdermal system)
30-Jun-2018
Pending
One or more studies to provide quantitative estimates of the serious risks of
misuse, abuse, addiction, overdose, and death associated with long-term use of
opioid analgesics for management of chronic pain, among patients prescribed
ER/LA opioid products. Include an assessment of risk relative to efficacy. These
studies should address at a minimum the following specific aims: a. Estimate the
incidence of misuse, abuse, addiction, overdose and death associated with longterm use of opioids for chronic pain. Stratify misuse and overdose by intentionality
wherever possible. Examine the effect of product/formulation, dose and duration
of opioid use, prescriber specialty, indication, and other clinical factors (e.g.,
concomitant psychotropic medications, personal or family history of substance
abuse, history of psychiatric illness) on the risk of misuse, abuse, addiction,
overdose and death. b. Evaluate and quantify other risk factors for misuse, abuse,
addiction, overdose, and death associated with long-term use of opioids for
chronic pain, including but not limited to the following: demographic factors,
psychosocial/behavioral factors, medical factors, and genetic factors. Identify
confounders and effect-modifiers of individual risk factor/outcome relationships.
Stratify misuse and overdose by intentionality wherever possible.
DURAGESIC® (fentanyl
transdermal system)
30-Nov-2015
Pending
Develop and validate measures of the following opioid-related adverse events:
misuse, abuse, addiction, overdose and death (based on Department of Health
and Human Services definition, or any agreed-upon definition), which will be used
to inform the design and analysis for PMR # 2065-1 and any future post-marketing
safety studies and clinical trials to assess these risks. This can be achieved by
conducting an instrument development study or a validation study of an algorithm
based on secondary data sources.
DURAGESIC® (fentanyl
transdermal system)
30-Nov-2015
Pending
A study to validate coded medical terminologies (e.g., ICD9, ICD10, SNOMED)
used to identify the following opioid-related adverse events: misuse, abuse,
addiction, overdose, and death in any existing post-marketing databases to
be employed in the studies. Stratify misuse and overdose by intentionality
wherever possible.
DURAGESIC® (fentanyl
transdermal system)
30-Nov-2015
Pending
A study to define and validate “doctor/pharmacy shopping” as outcomes
suggestive of misuse, abuse and/or addiction.
DURAGESIC® (fentanyl
transdermal system)
28-Feb-2017
Pending
A clinical trial to estimate the serious risk for the development of hyperalgesia
following use of extended release/long-acting opioid analgesics for at least one
year to treat chronic pain.
EDURANT® (rilpivirine)
Tablets
31-Mar-2019
Pending
A pediatric safety and antiviral activity study of rilpivirine with activity based on the
results of virologic response over at least 48 weeks of dosing and safety monitored
over 48 weeks in pediatric subjects from 4 weeks to <12 years of age.
Janssen Pharmaceutical Companies U.S. Post-Marketing Requirements and Commitments – October 2014
2
Product
Due Date
Status
Description of Commitment or Requirement
EDURANT® (rilpivirine)
Tablets
28-Feb-2015
Ongoing
A pediatric safety and antiviral activity study of rilpivirine with activity based on
results of virologic response over at least 48 weeks of dosing and safety monitored
over 48 weeks in pediatric subjects from 12 to <18 years of age.
INTELENCE® (etravirine)
31-Oct-2020
Ongoing
Deferred pediatric study under PREA for the treatment of HIV-1 infection in
pediatric subjects from 2 months to 6 years of age. This study will determine the
pharmacokinetic profile, safety, and activity of etravirine in pediatric subjects
from 2 months to 6 years of age.
INTELENCE® (etravirine)
30-Jun-2014
Submitted
A 48-week clinical trial of treatment-experienced patients enrolling at least 200
subjects to evaluate the safety and pharmacokinetics of etravirine when given
with drug combinations that do not contain darunavir/ritonavir.
INVEGA® (paliperidone)
28-Mar-2014
Submitted
An adequate and well-controlled long-term maintenance study to assess the
efficacy and safety of paliperidone ER or paliperidone palmitate in the treatment
of schizoaffective disorder.
INVOKANA® (canagliflozin)
30-Jun-2015
Pending
A clinical pharmacology study to evaluate the pharmacokinetics,
pharmacodynamics, and safety of canagliflozin in pediatric patients ages
10 to <18 years with type 2 diabetes mellitus on metformin monotherapy.
INVOKANA® (canagliflozin)
31-Dec-2020
Pending
A 26-week, randomized double-blind, placebo-controlled study, followed by a
26-week double-blind, placebo- or active-controlled extension, to evaluate the
efficacy and safety of canagliflozin compared to placebo in pediatric patients
ages 10 to <18 years with type 2 diabetes mellitus, as add-on to metformin and
as monotherapy.
INVOKANA® (canagliflozin)
30-Nov-2023
Pending
An assessment and analysis of all foreign and domestic spontaneous reports of
malignancy (pheochromocytoma, Leydig cell tumor, and renal cell carcinoma),
fatal pancreatitis, hemorrhagic/necrotizing pancreatitis, severe hypersensitivity
reactions (angioedema, anaphylaxis, Stevens-Johnson syndrome), photosensitivity
reactions, serious hepatic abnormalities, and pregnancy in patients treated with
canagliflozin. The enhanced pharmacovigilance should continue for 10 years from
the date of approval for malignancies and 5 years for all other events.
INVOKANA® (canagliflozin)
31-Dec-2013
Submitted
Completion and submission of the final report for the 78-week double-blind
extension phase of DIA3010, a clinical trial to assess the long-term safety
of canagliflozin, including, but not limited to, the effect of the addition of
canagliflozin to the addition of placebo on bone mineral density and markers
of bone turnover.
INVOKANA® (canagliflozin)
30-Sep-2017
Pending
A randomized, double-blind, placebo-controlled trial evaluating the effect of
canagliflozin on the incidence of major adverse cardiovascular events (MACE) in
patients with type 2 diabetes mellitus. The primary objective of the trial should be
to demonstrate that the upper bound of the 2-sided 95% confidence interval for
the estimated risk ratio comparing the incidence of MACE (non-fatal myocardial
infarction, non-fatal stroke, cardiovascular death) observed with canagliflozin to
that observed in the placebo group is less than 1.3.
INVOKAMET™
(canagliflozin and
metformin hydrochloride)
30-Nov-2017
Pending
A study to evaluate whether pediatric patients with type 2 diabetes ages 10-17
years (inclusive) or healthy pediatric subjects ages 10-17 years (inclusive) can safely
swallow INVOKAMET™ tablets. The study should evaluate tablets that are the
same dimensions as the largest INVOKAMET™ tablet, and placebo tablets should
be used if the study population consists of healthy subjects.
LEVAQUIN® (levofloxacin)
Tablets,
LEVAQUIN® (levofloxacin)
Injection,
LEVAQUIN® (levofloxacin)
Oral Solution
No Due Date
Pending
Cooperation with U.S.-based public health agencies in evaluating data on the use
of LEVAQUIN® (levofloxacin) in a large U.S. population for inhalational anthrax
(post-exposure) prophylaxis, should an exposure occur. This includes long-term
safety data from treatment greater than 28 days, if such data become available.
Janssen Pharmaceutical Companies U.S. Post-Marketing Requirements and Commitments – October 2014
3
Product
Due Date
Status
Description of Commitment or Requirement
LEVAQUIN® (levofloxacin)
Tablets,
LEVAQUIN® (levofloxacin)
Injection,
LEVAQUIN® (levofloxacin)
Oral Solution
No Due Date
Pending
Cooperation with U.S.-based public health agencies in evaluating data on the use
of LEVAQUIN® (levofloxacin) in a large U.S. population for inhalational anthrax
(post-exposure) prophylaxis, should an exposure occur. This includes long-term
safety data in pediatric patients from treatment greater than 14 days, if such data
become available.
LEVAQUIN® (levofloxacin)
Tablets,
LEVAQUIN® (levofloxacin)
Injection
31-Dec-2006
Submitted
Commitment to conduct post-marketing PK clinical trial in renally
impaired patients
LEVAQUIN® (levofloxacin)
Tablets,
LEVAQUIN® (levofloxacin)
Injection,
LEVAQUIN® (levofloxacin)
Oral Solution
No Due Date
Pending
A field study to evaluate the efficacy and safety of levofloxacin in the event of
an attack with the intentional release of Yersinia pestis in the United States.
NUCYNTA® (tapentadol)
Immediate Release Tablets
31-Mar-2019
Pending
A pharmacokinetic, efficacy and safety study of NUCYNTA® (tapentadol) for the
management of moderate to severe acute pain in pediatric patients ages 6 to less
than 17 years.
NUCYNTA® (tapentadol)
Immediate Release Tablets
31-Dec-2021
Pending
A pharmacokinetic, efficacy and safety study of NUCYNTA® (tapentadol) for the
management of moderate to severe acute pain in pediatric patients ages birth
to 5 years.
NUCYNTA® (tapentadol)
Oral Solution
31-Mar-2019
Pending
A pharmacokinetic, efficacy and safety study of NUCYNTA® (tapentadol) for the
management of moderate to severe acute pain in pediatric patients ages 6 to
less than 17 years.
NUCYNTA® (tapentadol)
Oral Solution
31-Dec-2021
Pending
A pharmacokinetic, efficacy and safety study of NUCYNTA® (tapentadol) for the
management of moderate to severe acute pain in pediatric patients ages birth
to 5 years.
NUCYNTA® ER (tapentadol)
31-Mar-2018
Pending
Deferred pediatric study required under PREA: A pharmacokinetic efficacy and
safety study of NUCYNTA® ER (tapentadol) for the management of chronic pain
in pediatric patients ages 7 to <17 years.
NUCYNTA® ER (tapentadol)
30-Jun-2018
Pending
Conduct one or more studies to provide quantitative estimates of the serious risks
of misuse, abuse, addiction, overdose, and death associated with long-term use
of opioid analgesics for management of chronic pain, among patients prescribed
ER/LA opioid products. Include an assessment of risk relative to efficacy. These
studies should address at a minimum the following specific aims:
a. Estimate the incidence of misuse, abuse, addiction, overdose and death
associated with long-term use of opioids for chronic pain. Stratify misuse and
overdose by intentionality wherever possible. Examine the effect of product/
formulation, dose and duration of opioid use, prescriber specialty, indication,
and other clinical factors (e.g., concomitant psychotropic medications, personal
or family history of substance abuse, history of psychiatric illness) on the risk of
misuse, abuse, addiction, overdose and death.
b. Evaluate and quantify other risk factors for misuse, abuse, addiction, overdose,
and death associated with long-term use of opioids for chronic pain, including
but not limited to the following: demographic factors, psychosocial/behavioral
factors, medical factors, and genetic factors. Identify confounders and effect
modifiers of individual risk factor/outcome relationships. Stratify misuse and
overdose by intentionality wherever possible.
Janssen Pharmaceutical Companies U.S. Post-Marketing Requirements and Commitments – October 2014
4
Product
Due Date
Status
Description of Commitment or Requirement
NUCYNTA® ER (tapentadol)
30-Nov-2015
Pending
Develop and validate measures of the following opioid-related adverse events:
misuse, abuse, addiction, overdose and death (based on DHHS definition, or any
agreed-upon definition), which will be used to inform the design and analysis for
PMR # 2065-1 and any future post-marketing safety studies and clinical trials to
assess these risks. This can be achieved by conducting an instrument development
study or a validation study of an algorithm based on secondary data sources.
NUCYNTA® ER (tapentadol)
30-Nov-2015
Pending
Conduct a study to validate coded medical terminologies (e.g., ICD9, ICD10,
SNOMED) used to identify the following opioid-related adverse events: misuse,
abuse, addiction, overdose, and death in any existing post-marketing databases
to be employed in the studies. Stratify misuse and overdose by intentionality
wherever possible. These validated codes will be used to inform the design
and analysis for PMR # 2065-1.
NUCYNTA® ER (tapentadol)
30-Nov-2015
Pending
A study to define and validate “doctor/pharmacy shopping” as outcomes
suggestive of misuse, abuse and/or addiction. These validated codes will
be used to inform the design and analysis for PMR # 2065-1.
NUCYNTA® ER (tapentadol)
28-Feb-2017
Pending
Conduct a clinical trial to estimate the serious risk for the development of
hyperalgesia following use of ER/LA opioid analgesics for at least one year to
treat chronic pain. We strongly encourage you to use the same trial to assess
the development of tolerance following use of ER/LA opioid analgesics. Include
an assessment of risk relative to efficacy.
PANCREAZE®
(pancrelipase)
31-Aug-2022
Ongoing
A 10 year, observational study to prospectively evaluate the incidence of f
ibrosing colonopathy in patients with cystic fibrosis treated with PANCREAZE®
(pancrelipase) Delayed-Release Capsules in the U.S. and to assess potential risk
factors for the event.
PANCREAZE®
(pancrelipase)
30-Sep-2022
Ongoing
A 10 year, observational study to prospectively evaluate the risk of transmission
of selected porcine viruses in patients taking PANCREAZE® (pancrelipase)
Delayed-Release Capsules.
PROCRIT® (epoetin alfa)
31-Mar-2018
Ongoing
Clinical trial EPO-ANE-3010 entitled, "A Randomized, Open-label, Multicenter,
Phase3 Study of Epoetin Alfa plus Standard Supportive Care versus Standard
Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving
Standard Chemotherapy" to evaluate the impact of epoetin alfa on overall
survival, progression-free survival, time to tumor progression and objective
tumor response rate.
REMICADE® (infliximab)
17-Jul-2008
Submitted
To collect additional infectious, autoimmune and neoplastic adverse event data in
patients receiving up to 10 mg/kg of infliximab every 4 to 8 weeks in combination
with methotrexate.
REMICADE® (infliximab)
31-Mar-2020
Ongoing
Requirement of all TNF-α blockers including REMICADE® (infliximab) to perform
enhanced PV for reports of malignancy in pediatric, adolescent, and young adult
patients for a period of up to 10 years.
REMICADE® (infliximab)
30-Jun-2019
Ongoing
A study to bank samples for future evaluation to identify genetic mutations and
other biomarkers that predispose inflammatory bowel disease (IBD) patients to
developing Hepatosplenic T-Cell Lymphoma (HSTCL).
REMICADE® (infliximab)
30-Dec-2045
Ongoing
Expansion the Pediatric IBD Registry (DEVELOP) to include pediatric patients
with ulcerative colitis (UC) and indeterminate colitis (IC).
REMICADE® (infliximab)
30-Jun-2018
Ongoing
A safety and pharmacokinetic trial as a substudy of the DEVELOP registry to
evaluate whether trough concentrations at the time of loss of clinical response
can be used to identify pediatric UC and Crohn's disease patients who have low
infliximab exposures and would benefit from a dose increase above that approved
without increasing risk of serious adverse events.
Janssen Pharmaceutical Companies U.S. Post-Marketing Requirements and Commitments – October 2014
5
Product
Due Date
Status
Description of Commitment or Requirement
REMICADE® (infliximab)
30-Dec-2013
Submitted
A survey of providers and patients during initial use of REMICADE® (infliximab)
for UC that will evaluate whether the risks of Hepatosplenic T-cell Lymphoma
are being adequately communicated to and understood by the patients and/or
their caregivers.
REMICADE® (infliximab)
30-Dec-2045
Ongoing
A study to analyze samples from the pediatric inflammatory bowel disease (IBD)
registry (DEVELOP) and the safety and pharmacokinetic trial as a substudy of the
DEVELOP registry to determine the presence of anti-drug antibodies (ADA).
REMICADE® (infliximab)
30-Sep-2013
Delayed
Conduct a prospective, observational registry study of women with Crohn's
disease, rheumatoid arthritis and psoriatic arthritis exposed to infliximab during
pregnancy. This study will assess the pregnancy outcomes in women who were
exposed to infliximab during pregnancy relative to background risk in similar
patients not exposed to infliximab.
REMICADE® (infliximab)
1-Dec-2018
Ongoing
A prospective, multi-center registry including 4000 adult psoriasis patients
treated with commercial REMICADE® (infliximab) in the United States. This
registry will characterize and assess the incidence of serious adverse events
(including serious infection, tuberculosis, opportunistic infections, malignancies,
hypersensitivity reactions, autoimmune reactions and deaths) as well as other
adverse events of interest in the study cohort. All enrolled study patients will
be evaluated twice yearly for a period of at least 8 years with comprehensive
annual reports provided to the agency. We will to collect data on the patient
characteristics, demographics and drug exposure (including dose, duration
and time to onset of adverse event). The collection of data will be via active
surveillance methods and data will be validated by a review of medical records
as per the Guidance for Industry: Good Pharmacovigilance Practices and
Pharmacoepidemiologic Assessment.
REMICADE® (infliximab)
30-Jun-2027
Ongoing
Conduct a registry of patients with pediatric Crohn's disease being treated with
REMICADE® (infliximab) that will be established to obtain long-term clinical status
and safety information. Information will be collected on patient demographics,
disease characteristics, history of concomitant medications, dose and duration
and frequency of REMICADE® (infliximab) administration, clinical status, adverse
events including dysplasias and malignancies of all types, infections, autoimmune
disease, assessment of immunogenicity, and potential effects of antibody
formation. The age range should include patients ages 0 to 19 years. This registry
will be designed so that detailed clinical status information is collected at registry
entry and on a 6-month basis for at least 20 years. We commit to expand the
currently existing Pediatric IBD Registry, and will actively encourage both patients
and physicians to participate in the registry through an advertisement campaign
that includes a plan for proactive communication of associated risk. We also
commit to recruiting at least 2,000 REMICADE® (infliximab)-treated pediatric
Crohn's patients, which will provide an adequate number of patients to participate
in the registry so that outcome measures will be collected and adequate risk
assessment can be made. We will provide prompt risk communication for serious
adverse events that are reported through the registry. The registry data will be
analyzed at yearly intervals and the results will be submitted in annual reports
for BB-IND 5389.
SIMPONI® (golimumab)
1-Apr-2014
Terminated
Assessment of the pharmacokinetics, safety, immunogenicity, and efficacy of
golimumab in pediatric patients 2 to 16 years of age with active polyarticular
juvenile idiopathic arthritis (pJIA).
SIMPONI® (golimumab)
1-Mar-2020
Ongoing
Enhanced pharmacovigilance (PV) for reports of malignancy in pediatric,
adolescent, and young adult patients for a period of up to 10 years. These
reports must be provided on an annual basis. The final annual report is due
on 01 Mar 2020.
Janssen Pharmaceutical Companies U.S. Post-Marketing Requirements and Commitments – October 2014
6
Product
Due Date
Status
Description of Commitment or Requirement
SIMPONI® (golimumab)
28-Feb-2021
Ongoing
A study to bank samples from inflammatory bowel disease patients treated with
SIMPONI® (golimumab) for future evaluation to identify genetic mutations and
other biomarkers that may predispose them to developing Hepatosplenic T-Cell
Lymphoma (HSTCL).
SIMPONI® (golimumab)
28-Feb-2021
Ongoing
A study to bank samples from inflammatory bowel disease patients treated with
SIMPONI® (golimumab) for future evaluation to identify genetic mutations and
other biomarkers that may predispose them to developing Hepatosplenic T-Cell
Lymphoma (HSTCL).
SIMPONI® (golimumab)
29-Apr-2014
Submitted
A study to reanalyze banked immunogenicity serum samples from ulcerative
colitis trials of SIMPONI® (golimumab), C0524T16, C0524T17 and C0524T18, to
determine the presence of anti-drug antibodies (ADA) using an improved ADA
assay format with reduced sensitivity to product interference.
SIMPONI® (golimumab)
31-May-2030
Pending
A prospective, multi-center, long-term, observational study of ulcerative colitis
patients treated with SIMPONI® (golimumab) in a routine clinical setting, to assess
the long-term safety of SIMPONI® (golimumab). The study’s primary outcome
should be the incidence of lymphoma. Design the study around a testable
hypothesis to rule out a clinically meaningful increase in lymphoma above an
estimated background risk in a suitable comparator. Secondary endpoints should
be pre-specified and may include the incidence of other malignancies. Select and
justify the choice of appropriate comparator population(s) and corresponding
background rate(s) relative to SIMPONI® (golimumab)-exposed patients. Provide
sample sizes and effect sizes that can be ruled out under various enrollment target
scenarios and loss to follow-up assumptions. Patients should be enrolled over
an initial 5-year period and then followed for a period of at least 10 years from
the time of enrollment. Progress updates of patient accrual and a demographic
summary should be provided in your annual reports. Safety data should be
provided in periodic safety reports.
SIMPONI® (golimumab)
31-May-2016
Ongoing
Conduct a study to evaluate the pharmacokinetics of SIMPONI® (golimumab) in
pediatric patients 5 to 17 years of age with moderately to severely active ulcerative
colitis. Pharmacokinetic measurements should be conducted for exposureresponse analysis and compared to adult patients with ulcerative colitis treated
with SIMPONI® (golimumab). Also, collect serum samples for immunogenicity
testing and conduct analyses of the impact of immunogenicity on the
pharmacokinetics of SIMPONI® (golimumab).
SIMPONI® (golimumab)
31-May-2022
Pending
A study to evaluate the effectiveness and safety of SIMPONI® (golimumab) in
pediatric patients 5 to 17 years of age with moderately to severely active ulcerative
colitis. The study should be designed to establish that the dose regimen(s) of
SIMPONI® (golimumab) identified in PMC #4 (pharmacokinetic pediatric UC
study) are effective and safe for induction treatment, as well as for continued
treatment after induction. Pharmacokinetic measurements should be conducted
for exposure-response analysis. Collect serum samples for immunogenicity testing
and conduct analyses of the impact of immunogenicity on pharmacokinetics,
efficacy and safety.
SIMPONI® ARIA™
(golimumab)
31-Dec-2018
Pending
A trial to evaluate the safety, efficacy, PK/PD and immunogenicity of IV golimumab
in pediatric patients between the ages 2 to 17 years and 11 months with active
juvenile idiopathic arthritis (JIA) despite standard therapy with methotrexate.
SIRTURO® (bedaquiline)
31-Mar-2022
Ongoing
A confirmatory randomized double blind placebo controlled multicenter Phase
3 trial in subjects with sputum smear-positive pulmonary multidrug resistant
tuberculosis (MDR-TB). This trial should assess long-term outcomes of failure or
relapse or death at least 6 months after all MDR-TB treatment is completed.
Janssen Pharmaceutical Companies U.S. Post-Marketing Requirements and Commitments – October 2014
7
Product
Due Date
Status
Description of Commitment or Requirement
SIRTURO® (bedaquiline)
31-Aug-2019
Ongoing
Develop a patient registry for bedaquiline-treated patients to assess incidence
rates of serious adverse events, including death. The registry should capture
the information listed below: a. Indication for use, including utilization of expert
medical consultation. b. Minimum Inhibitory Concentration (MIC) data for
baseline and any subsequent MDR-TB isolate (in patients who have relapsed/ at
end of treatment). c. Drug Utilization Data. d. Information on drug distribution
mechanisms used. e. Information on how the drug was actually distributed to
patients. f. Patient outcomes (clinical and microbiologic). g. Safety assessments
in bedaquiline-treated patients, including deaths. h. Concomitant medications.
SIRTURO® (bedaquiline)
31-Dec-2014
Ongoing
A study to define the quality control ranges of bedaquiline for MDR-TB isolates
using standard proportion methods.
SIRTURO® (bedaquiline)
31-Dec-2014
Ongoing
A study to define the quality control ranges of bedaquiline for MDR-TB isolates
using MIC methods.
SIRTURO® (bedaquiline)
31-Dec-2019
Pending
A prospective in vitro study over a five-year period after introduction of SIRTURO®
(bedaquiline) to the market to determine MICs of MDR-TB isolates to bedaquiline
for the first 5 years from marketing. Report interpretation of these MICs once
additional quality control testing methods are developed as noted in the required
post-marketing studies PMR 1988-03 and PMR 1988-004. Provide detailed protocol
describing the study to the Agency for review and comment before commencing
the study.
SIRTURO® (bedaquiline)
31-Dec-2013
Submitted
An in vitro study to characterize the potential of bedaquiline and M2 as a substrate,
inhibitor or inducer of the OATP1B1 and OATP1B3 drug transporters.
SIRTURO® (bedaquiline)
30-Nov-2013
Submitted
Submit final study report and electronic data for Study C208 Stage II.
SIRTURO® (bedaquiline)
30-Nov-2013
Submitted
Submit final study report and electronic data for Study C209.
SPORANOX® (itraconazole)
Capsules
No Due Date
Submitted
Investigate the pharmacokinetics of itraconazole in patients during the course
of their treatment with itraconazole using a pharmacokinetic approach.
STELARA® (ustekinumab)
1-Dec-2022
Pending
Conduct studies to evaluate the safety and efficacy of ustekinumab in pediatric
subjects with plaque psoriasis.
STELARA® (ustekinumab)
1-Dec-2020
Ongoing
Enroll 4,000 STELARA® (ustekinumab)-treated subjects into the Psoriasis
Longitudinal Assessment Registry, (PSOLAR) and follow for 8 years from the time
of enrollment. Subjects will be followed for the occurrence of serious infection,
tuberculosis, opportunistic infections, malignancy, hypersensitivity reactions,
autoimmune disease, neurologic or demyelinating disease, cardiovascular,
gastrointestinal or hematologic adverse events.
STELARA® (ustekinumab)
15-Dec-2020
Ongoing
Provide data analyses from the Nordic Database Initiative regarding the
occurrence of serious infection, tuberculosis, opportunistic infections,
malignancy, hypersensitivity reactions, autoimmune disease, neurologic
or demyelinating disease, cardiovascular, gastrointestinal or hematologic
adverse events with exposure to ustekinumab.
STELARA® (ustekinumab)
15-Jul-2014
Delayed
Establish a U.S.-based prospective, observational pregnancy exposure registry
that compares the pregnancy and fetal outcomes of women exposed to STELARA®
(ustekinumab) during pregnancy to an unexpected control population. Outcomes
of the registry should include major and minor congenital anomalies, spontaneous
abortions, stillbirths, elective terminations, adverse effects on immune system
development, and other serious adverse pregnancy outcomes. These outcomes
should be assessed throughout pregnancy. Infant outcomes should be assessed
through at least the first year of life.
Janssen Pharmaceutical Companies U.S. Post-Marketing Requirements and Commitments – October 2014
8
Product
Due Date
Status
Description of Commitment or Requirement
STELARA® (ustekinumab)
15-Dec-2021
Ongoing
Provide data analyses from the Pregnancy Research Initiative (study C0168T71).
STELARA® (ustekinumab)
18-Nov-2015
Ongoing
Provide information on maintenance of response with dosing intervals longer
than every 12 weeks among relevant populations (e.g., subjects whose psoriasis
is cleared as measured by PGA and PASI or who have minimal psoriasis). This
information will be obtained from a study of at least 300 subjects treated with
STELARA® (ustekinumab) for a minimum of one year.
SYLVANT™ (siltuximab)
31-Aug-2017
Ongoing
Complete the trial and submit the final report of CNTO328MCD2002 “An OpenLabel, Multicenter Study to Evaluate the Safety of Long-Term Treatment with
Siltuximab in Subjects with Multicentric Castleman’s Disease.”
TOPAMAX® (topiramate)
Tablets
15-Sep-2018
Pending
A one year prospective, randomized, parallel, active-control arm trial to compare
the safety of TOPAMAX® (topiramate) with regard to metabolic acidosis, renal
stone formation, bone mineral density, and development (i.e. height, weight
and sexual) with that of an alternate treatment in pediatric patients ages 2 to 15
years. Dosing for this study should be based on the pediatric monotherapy dosing
recommendations in the approved labeling for TOPAMAX® (topiramate) and an
expected efficacious dose for the comparator.
TOPAMAX® (topiramate)
Sprinkle Capsules
15-Sep-2018
Pending
A one year prospective, randomized, parallel, active-control arm trial to compare
the safety of TOPAMAX® (topiramate) with regard to metabolic acidosis, renal
stone formation, bone mineral density, and development (i.e. height, weight
and sexual) with that of an alternate treatment in pediatric patients ages 2 to 15
years. Dosing for this study should be based on the pediatric monotherapy dosing
recommendations in the approved labeling for TOPAMAX® (topiramate) and an
expected efficacious dose for the comparator.
ULTRAM® (tramadol
hydrochloride)
30-Sep-2014
Submitted
A multiple ascending dose clinical trial in healthy adult volunteers to determine
the maximum tolerated dose of tramadol and to inform the dosing for a thorough
QT trial of tramadol.
ULTRAM® (tramadol
hydrochloride)
30-Jul-2015
Pending
A clinical trial in healthy adult volunteers to assess the risk of QT prolongation
with tramadol, i.e., a thorough QT (tQT) trial. This trial will provide information
on cardiac depolarization and conduction effects of tramadol at therapeutic and
supratherapeutic dose regimens. The tQT trial may be conducted as part of the
multiple ascending dose trial.
ULTRACET® (tramadol
hydrochloride/
acetaminophen)
30-Sep-2014
Submitted
A multiple ascending dose clinical trial in healthy adult volunteers to determine
the maximum tolerated dose of tramadol and to inform the dosing for a thorough
QT trial of tramadol.
ULTRACET® (tramadol
hydrochloride/
acetaminophen)
30-Jul-2015
Pending
A clinical trial in healthy adult volunteers to assess the risk of QT prolongation
with tramadol, i.e., a thorough QT (tQT) trial. This trial will provide information
on cardiac depolarization and conduction effects of tramadol at therapeutic and
supratherapeutic dose regimens. The tQT trial may be conducted as part of the
multiple ascending dose trial.
ULTRACET® (tramadol
hydrochloride/
acetaminophen)
15-May-2005
Submitted
Pediatric study commitment; final study report for TRAMAP-PEDS-001. Study
TRAMAP-PEDS-001 compared the safety and clinical effectiveness of single doses
of tramadol 75 mg/APAP 650 mg, tramadol 37.5 mg/APAP 325 mg, and placebo
in pediatric participants, aged 8 to 17 years, with post-surgical pain. This study
enrolled 150 participants at 20 study centers in the United States and Costa Rica.
XARELTO® (rivaroxaban)
Tablets, 10 mg
30-Dec-2018
Ongoing
A post-marketing pharmacovigilance study of the risk factors, clinical
management, and outcome of cases of major bleeding in association with
XARELTO® (rivaroxaban) use.
Janssen Pharmaceutical Companies U.S. Post-Marketing Requirements and Commitments – October 2014
9
Product
Due Date
Status
Description of Commitment or Requirement
XARELTO® (rivaroxaban)
Tablets, 15 mg and 20 mg
30-Jun-2015
Ongoing
A single-dose PK/PD and tolerability trial in pediatric patients aged ≥6 months to
<17 years with VTE in appropriate age cohorts to determine dosing of rivaroxaban
(tablets and oral suspension) that will provide similar exposure and/or PD effect
compared to recommended doses in adults. Enroll into sequential age cohorts
(e.g., beginning with 12 to <17 years) and use the information from the older age
cohorts to inform dosing in the younger age cohorts.
XARELTO® (rivaroxaban)
Tablets, 15 mg and 20 mg
30-Jun-2017
Ongoing
A randomized, dose-exploration, multicenter clinical trial evaluating the multiple
dose PK/PD profile and safety of oral rivaroxaban (tablets or oral suspension) in
pediatric patients aged 6 years to <17 years with VTE. Enroll into sequential age
cohorts (e.g., beginning with ages 12 to < 17 years) and use the information from
the older age cohorts to inform dosing in the younger age cohorts.
XARELTO® (rivaroxaban)
Tablets, 15 mg and 20 mg
30-Jun-2020
Ongoing
A randomized, dose-exploration, multicenter clinical trial evaluating the multiple
dose PK/PD profile and safety of oral rivaroxaban (tablets or oral suspension) in
pediatric patients aged 6 months to < 6 years with VTE.
XARELTO® (rivaroxaban)
Tablets, 15 mg and 20 mg
30-Jun-2020
Ongoing
A single-dose PK/PD and tolerability trial in pediatric patients age birth to < 6 months
with VTE to determine doses of rivaroxaban (oral suspension) that provide similar
exposure and/or PD effect to those seen in older pediatric cohorts.
XARELTO® (rivaroxaban)
Tablets, 15 mg and 20 mg
30-Jun-2020
Ongoing
A dose-exploration, multicenter clinical trial evaluating the multiple dose PK/PD
profile and safety of oral rivaroxaban (oral suspension) in pediatric patients aged
birth to <6 months with VTE.
XARELTO® (rivaroxaban)
Tablets, 15 mg and 20 mg
30-Jun-2020
Ongoing
A randomized, active-controlled, multicenter clinical trial evaluating the safety,
efficacy and PK/PD (sparse sampling) of at least 3 months of treatment with oral
rivaroxaban (tablets or oral suspension) in pediatric patients aged birth to < 17
years of age who have acute VTE. Patients who require treatment for longer than
3 months will be offered continuation of treatment in an open label extension of this
study with treatment duration of up to 12 months. Patients from birth to <6 months
of age may be enrolled only after data from a planned interim analysis have
shown efficacy and safety of rivaroxaban in the older pediatric age groups.
Age distribution of patients in the study should reflect the occurrence of
VTE in the pediatric population.
ZYTIGA®
(abiraterone acetate)
30-Sep-2014
Ongoing
Submit datasets and the final analysis of overall survival for COU-AA-302.
OLYSIO™ (simeprevir)
31-Dec-2021
Pending
A trial to evaluate the pharmacokinetics, safety and treatment response (using
sustained virologic response) of OLYSIO™ (simeprevir) as a component of a
combination antiviral treatment regimen in pediatric subjects 3 through 17 years
of age with chronic hepatitis C.
OLYSIO™ (simeprevir)
31-Jan-2025
Pending
Collection of long-term safety data for subjects enrolled in the pediatric
simeprevir safety, pharmacokinetic and efficacy trial. Data collected should
include at least 3 years of follow-up in order to characterize the long-term safety
of OLYSIO™ (simeprevir) in pediatric subjects, including growth assessment,
sexual maturation and characterization of OLYSIO™ (simeprevir) resistanceassociated substitutions in viral isolates from subjects failing therapy.
OLYSIO™ (simeprevir)
31-Jul-2014
Submitted
A study to determine the phenotypic susceptibility of TMC435 against: L356F,
V406I, or V629I expressed in genotype 1a replicon cultures, individually and
in combination with Q80K R24W, K213R, T358F, P574A, P574S, T610I, or V629I
expressed in genotype 1b replicon cultures
OLYSIO™ (simeprevir)
31-Jul-2015
Ongoing
Submit the final report and datasets from the ongoing clinical trial
TMC435HPC3005 entitled “A Phase 3, Randomized, Double-Blind, Double-Dummy,
Placebo-Controlled Study Conducted in the Asia-Pacific Region to Investigate the
Efficacy, Pharmacokinetics, Safety and Tolerability of TMC435 vs. Placebo as Part of
a Treatment Regimen Including Peginterferon alfa-2a and Ribavirin in Treatmentnaïve, Genotype 1 Hepatitis C-Infected Subjects.”
Janssen Pharmaceutical Companies U.S. Post-Marketing Requirements and Commitments – October 2014
10
Product
Due Date
Status
Description of Commitment or Requirement
OLYSIO™ (simeprevir)
31-Dec-2014
Ongoing
Submit the final report and datasets for trial HPC3001, entitled, “A Phase 3,
Randomized, Double-Blind Trial to Evaluate the Efficacy, Safety and Tolerability
of TMC435 versus Telaprevir, both in Combination with PegIFNα-2a and Ribavirin,
in Chronic Hepatitis C Genotype-1 Infected Subjects who were Null or Partial
Responders to Prior PegIFNα and Ribavirin Therapy.”
OLYSIO™ (simeprevir)
31-Oct-2014
Submitted
Submit the final report and datasets for trial TMC435HPC2002, entitled, “An
Exploratory Phase 2a, Randomized, Open-Label Trial to Investigate the Efficacy
and Safety of 12 weeks or 24 weeks of TMC435 in Combination with PSI-7977 with or
without Ribavirin in Chronic Hepatitis C Genotype 1 Infected Prior Null Responders
to Peginterferon/Ribavirin Therapy or HCV Treatment-Naïve Subjects.”
OLYSIO™ (simeprevir)
31-May-2014
Submitted
Submit the final report and datasets for trial TMC435-TiDP16-c212, entitled,
“A Phase 3 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of
TMC435 Plus PegIFNα-2a (Pegasys®) and Ribavirin (Copegus®) Triple Therapy in
Chronic Hepatitis C Genotype-1 Infected Subjects who are Co-Infected with
Human Immunodeficiency Virus Type 1 (HIV-1).”
Janssen Pharmaceutical Companies U.S. Post-Marketing Requirements and Commitments – October 2014