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](/docs-images/90/103470094/images/1-0.jpg "final analysis of overall survival (OS) for CRAD001T2302 and include final OS data in the product label Arranon Nelarabine 021877 28-Oct-2005 Subpart H PMC Submit results of Phase III trial AALL0434")
1 Novartis Pharmaceuticals Corporation - US Postmarketing s [October 2018] /Description 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 CRAD001T2302 and include final OS data in the product label Arranon Nelarabine Oct-2005 Subpart H PMC Submit results of Phase III trial AALL Dec Dec-2016 Delayed Arranon Nelarabine Jul-2018 Characterize the neurological adverse reactions to nelarabine with regard to time to onset, maximum grade and duration. Submit a description of the results of the analysis, data files used to perform the 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. 31-Aug 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 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# 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 30-Jun Sep Jul Jul Jul-2019
2 Novartis Pharmaceuticals Corporation - US Postmarketing s [October 2018] /Description Entresto Sacubitril, Valsartan Jul-2015 PMR# Clinical study CLCZ696B2320, 31-Mar-2022 evaluating the effects of Entresto compared to valsartan on cognitive function Exjade Deferasirox Nov-2005 PMC MDS Postmarketing study 31-Dec-2009 Exjade Deferasirox Nov-2005 PMC Opthamologic Postmarketing study 30-Sep-2012 Delayed 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-Sep-2018 Exjade Deferasirox Nov-2005 PMR NTDT 31-Dec-2021 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 combination with subcutaneous bortezomib and dexamethasone Gilenya Gilenya Gilenya Fingolimod Fingolimod Fingolimod 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 31-Dec Dec Oct Jul-2015 Delayed Delayed Ilaris Canakinumab Jun-2009 PMR #2 (SJIA) - SJIA Patient Registry 30-Jun-2023 Jadenu Deferasirox Mar-2015 PMR Nov-2019 Jadenu Deferasirox Mar-2015 PMR Nov-2019
3 Novartis Pharmaceuticals Corporation - US Postmarketing s [October 2018] /Description Jadenu Deferasirox Mar-2015 PMR Sep-2018 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 Nov-2019 Jadenu Deferasirox May-2017 PMR Nov-2019 Jadenu Deferasirox May-2017 PMR Nov-2019 Jadenu Deferasirox 18-May-2017 PMR Sep Kisqali Ribociclib Mar-2017 PMR Conduct clinical trial of alternative dosing regimen to mitigate QT prolongation risk. 31-Oct-2022 Pending Kisqali Ribociclib Mar-2017 PMR Complete renal impairment trial A2116 Kisqali Ribociclib Mar-2017 PMC Submit third and final OS data and analysis A2301 Kisqali Ribociclib Mar-2017 PMC Conduct in vitro studies to evaluate discriminatory ability of dissolution acceptance criterion and collect in vivo PK data 30-Apr Jun Sep-2018 Pending Kisqali Ribociclib Jul Submit the interim overall survival (OS) report with data and analysis; the final OS report with data and analysis from clinical trial MONALEESA Jun-2021 Kisqali Ribociclib Jul Submit the interim overall survival (OS) 31-Mar-2023 report with data and analysis; the final OS report with data and analysis, from clinical trial MONALEESA-3
4 Novartis Pharmaceuticals Corporation - US Postmarketing s [October 2018] /Description Kymriah Tisagenlecleucel Aug-2017 PMR Clinical Study CCTL019B2401: A postmarketing, 31-Dec-2038 Pending prospective, multi-center, observational study to assess the long-term safety of tisagenlecleucel and the risk of all secondary malignancies occurring after treatment with tisagenlecleucel. Kymriah Tisagenlecleucel May-2018 PMR Clinical Study CCTL019B2401: A postmarketing, 31-Dec-2038 Pending prospective, multi-center, observational study to assess the long-term safety of tisagenlecleucel Mekinist Trametinib May-2013 PMR Cardiomyopathy 30-Sep-2020 Mekinist Trametinib May-2013 PMR Ocular Toxicity 30-Sep-2016 Delayed Mekinist Trametinib May-2013 PMR Hepatic Impairment Pharmacokinetic 31-Dec-2015 Delayed Trial Mekinist Trametinib Jun-2017 PMC Final Anlyasis of Study BRF Jan-2020 /CDRB436E2201 Mekinist Trametinib May-2018 PMC : Final Report/Analysis for BRF / 31-Mar-2021 CDRB436X2201 Mekinist Trametinib May-2018 PMC : Establish in-vitro diagnostic device for 29-May-2020 ATC Rydapt Midostaurin Apr-2017 PMR Establish a worldwide Pregnancy 30-Jun-2027 Surveillance Program (enhanced pharmacovigilance) to collect and analyze information for a min of 10 years on pregnancy complications and birth outcomes Rydapt Midostaurin Apr-2017 PMC : Efficacy Analysis by Genomic Muation 31-Oct-2018 Subgroups Rydapt Midostaurin Apr-2017 PMC : Effiacay analysis by 31-Oct-2018 cytogenetic/molecular prognostic information for patients in RATIFY Signifor Pasireotide Dec-2012 PMR#1985-1: Registry 29-Nov-2024 Signifor Pasireotide Dec-2012 PMR#1985-2: Pharmacovigilance 29-Jun-2018
5 Novartis Pharmaceuticals Corporation - US Postmarketing s [October 2018] /Description Signifor Pasireotide Dec-2012 PMR#1985-3: Hyperglycemia Study 29-Jun-2018 Delayed Tafinlar Dabrafenib May-2013 PMR Secondary Malignancies 31-Oct-2020 Tafinlar Dabrafenib May-2013 PMR Cardiac Valve Abnormalities 30-Nov-2020 Tafinlar Dabrafenib May-2013 PMR Hepatic Impairment Pharmacokinetic Trial 30-Jun-2015 Delayed Tafinlar Dabrafenib May-2013 PMR Renal Impairment Pharmacokinetic Trial 30-Jun-2015 Delayed Tafinlar Dabrafenib Jun-2017 PMC Final Analysis of Study BRF / CDRB436E2201 Tafinlar Dabrafenib May-2018 PMC : Final Report/Analysis for BRF / CDRB436X2201 Tafinlar Dabrafenib May-2018 PMC : Establish in-vitro diagnostic device for ATC Dec-2017 PMR Characterize the risk of relapse after TFR - 60 months follow-up Dec-2017 PMR Characterize the potential risk of resistance to treatment after discontinuation - 10 years total Dec-2017 PMR Characterize safety for patients still in remission or experienced loss of MMR - 10 years total Mar-2018 PMR Characterize the long-term safety of treatment Mar-2018 PMR Characterize the effect of treatment with on growth and development Tobi Podhaler Tobramycin Mar-2013 Postmarketing requirement Observational 5 year study in the United States after marketing authorization 31-Jan Mar May Oct Feb Feb Jun Jun Jul-2021
6 Novartis Pharmaceuticals Corporation - US Postmarketing s [October 2018] /Description Tobi Podhaler Tobramycin Mar-2013 Postmarketing requirement Observational study in the United States of CF patients chronically colonized with P. aeruginosa Tobi Podhaler Tobramycin Mar-2013 PMR A multicenter, human factors validation study in cystic fibrosis patients aged 6 years and older to evaluate the user interface of TOBI Podhaler (tobramycin inhalation powder) using placebo capsules Tykerb Lapatinib Jan-2010 PMR : Study CLAP016A2307 (EGF114299) Efficacy study in postmenopausal women with HR+ MBC that overexpresses the HER2 receptor and who have received prior trastuzumab and endocrine therapies. 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 31-Jul May May Mar Mar-2017 * H = CFR Subpart H; F = FDAAA (o) (3) (PMR); P = PREA (required pediatric studies); C = PMC only
Novartis Pharmaceuticals Corporation - US Postmarketing Commitments October 2016 (Ongoing)
Novartis Pharmaceuticals Corporation - US Postmarketing Commitments October 2016 () Brand Name Generic Name Application Commitment Number Approval Date Commitment Number/Description Afinitor Everolimus
Novartis Pharmaceuticals Corporation - US Postmarketing Commitments Fulfilled [October 2018]
![Novartis Pharmaceuticals Corporation - US Postmarketing Commitments Fulfilled [October 2018]](/thumbs/94/118769546.jpg "Novartis Pharmaceuticals Corporation - US Postmarketing Commitments Fulfilled [October 2018]")
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
Novartis Pharmaceuticals Corporation - US Postmarketing Commitments October 2016 (Fulfilled)
Novartis Pharmaceuticals Corporation - US Postmarketing Commitments October 2016 () Brand Name Generic Name Application Commitment Date Description of Postmarketing PMC identifier Number (Approval Date)
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