Novartis Pharmaceuticals Corporation - US Postmarketing Commitments October 2016 (Ongoing)
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1 Novartis Pharmaceuticals Corporation - US Postmarketing Commitments October 2016 () Brand Name Generic Name Application Commitment Number Approval Date Commitment Number/Description Afinitor Everolimus BHT Mar-2009 PMC# Conduct a 3-arm trial of eve+exe vs. eve vs. capecitabine in HR+ advanced BC Afinitor Everolimus BHT Mar-2009 PMR#3031-1: To submit the clinical study report and datasets for the final analysis of overall survival (OS) for Trial CRAD001T2302 Arranon Nelarabine Oct-2005 Subpart H PMC Submit results of Phase III trial AALL0434 Coartem Artemether, Apr-2009 PMR Conduct a descriptive study of the Lumefantrine use of Coartem Tablets in non-immune travelers (Protocol CCOA566A2424) Commitment Due Date 31-Aug Dec Dec Apr-2016 Status Coartem Artemether, Lumefantrine Apr-2009 PMR Submit surveillance reports to evaluate the potential development of resistance to Coartem Tablets 31-Aug-2016 Cosentyx Secukinumab BLA 125, Jan-2015 PMR Conduct a study to evaluate the safety and efficacy of secukinumab in pediatric subjects 6 years of age with plaque psoriasis. 28-Feb-2026 Cosentyx Secukinumab BLA 125, Jan-2015 PMR Long term safety of secukinumab compared to other therapies (CORRONA Registry Study) Cosentyx Secukinumab BLA 125, Jan-2015 PMR # Completion of the treatment and evaluation of subjects enrolled in the ongoing CAIN457A2302E1 trial for a duration of 4 years 30-Jun Sep-2018
2 Novartis Pharmaceuticals Corporation - US Postmarketing Commitments October 2016 () Cosentyx Secukinumab BLA 125, Jan-2015 PMR# Completion of the treatment and evaluation of subjects enrolled in the ongoing CAIN457A2304E1 trial for a duration of 4 years Cosentyx Secukinumab BLA 125, Jan-2015 PMC# to Assess whether secukinumab alters the metabolism or pharmacokinetics of CYP substrates in psoriasis patients treated with secukinumab Cosentyx Secukinumab BLA 125, Jan-2015 PMC# Evaluate the treatment effect and safety profile of a higher exposure (e.g., 450 mg) of secukinumab in psoriasis subjects Entresto Sacubitril, Valsartan Jul-2015 PMR# Epidemiologic study evaluating the incidence of angioedema in Black patients Entresto Sacubitril, Valsartan Jul-2015 PMR# Clinical study CLCZ696B2320, evaluating the effects of Entresto compared to valsartan on cognitive function Exjade Deferasirox Nov-2005 PMC Pediatric Registry Postmarketing study 31-Jul May Jul Jul Mar Feb-2016 Exjade Deferasirox Nov-2005 PMC MDS Postmarketing study 31-Dec-2014 Exjade Deferasirox Nov-2005 PMC Opthamologic Postmarketing study 30-Sep-2012 Exjade Deferasirox Nov-2005 PMR NTDT 30-Nov-2019 Exjade Deferasirox Nov-2005 PMR NTDT 30-Nov-2019 Exjade Deferasirox Nov-2005 PMR NTDT 30-Nov-2018 Exjade Deferasirox Nov-2005 PMR NTDT 31-Dec-2021
3 Novartis Pharmaceuticals Corporation - US Postmarketing Commitments October 2016 () Exjade Deferasirox Nov-2005 PMR NTDT (Non-Transfusion Dependent 31-Jul-2019 Thalassemia syndromes) Exjade Deferasirox Nov-2005 PMR NTDT 30-Nov-2019 Farydak Panobinostat Feb-2015 PMR Randomized Phase 2 clinical trial of panobinostat in combination with subcutaneous bortezomib and dexamethasone 31-Aug-2019 Farydak Panobinostat Feb-2015 PMR Phase 3 Trial of panobinostat in 31-Dec-2021 combination with subcutaneous bortezomib and dexamethasone Foradil Formoterol Feb-2001 PMR LABA safety 30-Apr Sep-2010 PMR# Deferred pediatric study 1-Jan Sep-2010 PMR# Postmarketing observational prosepective, parallel cohort study in relapsing MS patients Sep-2010 PMR# Prospective, observational pregnancy exposure registry Sep-2010 PMC# A prospective, randomized, controlled study of fingolimod 0.5 mg, fingolimod 0.25 mg, and an appropriate control 15-Dec Oct Jul-2015 Ilaris Canakinumab Jun-2009 PMR #2 (SJIA) - SJIA Patient Registry 30-Jun-2023 Ilaris Canakinumab /23/2016 FDA PMC# Final CSR N2301 Epoch 3 31-Oct-16 Data Jadenu Deferasirox Mar-2015 PMR Feb-2016 Jadenu Deferasirox Mar-2015 PMR Nov-2019 Jadenu Deferasirox Mar-2015 PMR Nov-2015 Jadenu Deferasirox Mar-2015 PMR Sep-2018
4 Novartis Pharmaceuticals Corporation - US Postmarketing Commitments October 2016 () Jadenu Deferasirox Mar-2015 PMR Dec-2021 Jadenu Deferasirox Mar-2015 PMR Dec-2019 Jadenu Deferasirox Mar-2015 PMR Dec-2019 Jadenu Deferasirox Mar-2015 PMR Dec-2019 Jadenu Deferasirox ICL Mar-2015 PMR Jul-2019 Mekinist Trametinib May-2013 PMR Cardiomyopathy 30-Sep-2020 Mekinist Trametinib May-2013 PMR Ocular Toxicity 30-Sep-2016 Mekinist Trametinib May-2013 PMR Hepatic Impairment Pharmacokinetic Trial Odomzo Sonidegib Jul-2015 PMR# A 6-month carcinogenicity study in the transgenic mouse Odomzo Sonidegib Jul-2015 PMR# A long-term rodent carcinogenicity study in the rat Odomzo Sonidegib Jul-2015 PMR# A Pregnancy Pharmacovigilance Study to evaluate pregnancy outcomes and infant outcomes Odomzo Sonidegib Jul-2015 PMR# Study CLDE225A2113 pharmacokinetic trial in patients with moderate to severe hepatic impairment Odomzo Sonidegib Jul-2015 PMR# Study CLDE225A2118 pharmacokinetic (drug interaction) trial with esomeprazole 31-Dec Dec Dec Jul Jul Jan-2016 Signifor Pasireotide Dec-2012 PMR#1985-1: Registry 29-Nov-2024 Signifor Pasireotide Dec-2012 PMR#1985-2: Pharmacovigilance 29-Jun-2018 Signifor Pasireotide Dec-2012 PMR#1985-3: Hyperglycemia Study 29-Jun-2018 Tafinlar Dabrafenib May-2013 PMR Secondary Malignancies 31-Oct-2020 Tafinlar Dabrafenib May-2013 PMR Cardiac Valve Abnormalities 30-Nov-2020
5 Novartis Pharmaceuticals Corporation - US Postmarketing Commitments October 2016 () Tafinlar Dabrafenib May-2013 PMR Hepatic Impairment 30-Jun-2015 Pharmacokinetic Trial Tafinlar Dabrafenib May-2013 PMR Renal Impairment Pharmacokinetic 30-Jun-2015 Trial Tafinlar Dabrafenib May-2013 PMR Drug-Drug Interaction Trial 30-Jun-2015 Tafinlar Dabrafenib May-2013 PMC Drug-Drug Interaction Trial 31-Dec-2016 Tobi Podhaler Tobramycin Mar-2013 Postmarketing requirement Jul-2021 Observational 5 year study in the United States after marketing authorization Tobi Podhaler Tobramycin Mar-2013 Postmarketing requirement Observational study in the United States of CF patients chronically colonized with P. aeruginosa 31-Jul-2017 Tobi Podhaler Tobramycin Mar-2013 Postmarketing commitment Create adjunct instructions for use using alternative media and validate these instructions Tykerb Lapatinib Jan-2010 A randomized trial comparing lapatinib in combination with trastuzumab and an Tyzeka Telbivudine and Oct-2006 PMR : Conduct pediatric PK, dose selection, and treatment trial(s) in patients from birth to < 2 years of age Tyzeka Telbivudine and Oct-2006 PMR : Conduct pediatric PK, dose selection, safety, and treatment trial(s) in patients from 2 to < 18 years of age Zykadia Ceritinib Apr-2014 FDA PMR Clinical Study LDK378A2301 and/or LDK378A2303 establishing superiority over standard therapy 30-Nov May Dec Sep Oct-2019
6 Novartis Pharmaceuticals Corporation - US Postmarketing Commitments October 2016 () Zykadia Ceritinib Apr-2014 FDA PMR Clinical Study LDK378A2112 to evaluate 450mg dose + meal vs 600mg dose+ light meal vs 750mg in fasted state Zykadia Ceritinib Apr-2014 FDA PMR clinical study LDK378A2110 pharmacokinetic study in patients with hepatic impairement Zykadia Ceritinib Apr-2014 FDA PMR Clinical Study LDK378A2103 Midazolam Drug interaction Pharmacokinetic study Zykadia Ceritinib Apr-2014 FDA PMR Clinical Study LDK378A2103 Warfarin Drug Interaction pharmacokinetic study 30-Sep Jun Mar Mar-2017 ongoing
Novartis Pharmaceuticals Corporation - US Postmarketing Commitments Ongoing [October 2018]
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Novartis Pharmaceuticals Corporation - US Postmarketing s [October 2018] /Description Afinitor Everolimus BHT 22334 30-Mar-2009 PMR#3031-1: To submit the clinical study report and datasets for the final
Novartis Pharmaceuticals Corporation - US Postmarketing Commitments Fulfilled [October 2018]
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Afinitor everolimus 22334 3/30/2009 610-1 Conduct a trial in patients with severe hepatic impairment (Child Pugh Class C). This trial need not be conducted in patients with cancer and a single dose evaluation
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