List of Determinations

Abacavir/ dolutegravir/ lamivudine ViiV Healthcare Company 6/7/2023 Abatacept BMS 2/14/2017
  Acetaminophen Mallinckrodt 7/11/2016 Afatinib  Boehringer Ingelheim Pharmaceuticals, Inc. 3/8/2022 Aflibercept Regeneron Pharmaceuticals 10/18/2022 Albuterol GlaxoSmithKline 8/27/2008 Alfuzosin Sanofi Aventis 9/7/2010 Aliskiren Noden Pharma DAC 10/3/2017 Almotriptan Johnson & Johnson Pharmaceutical Research & Development 1/13/2009 Amphetamine Shire 8/18/2019 Anastrozole AstraZeneca 11/14/2007 Apremilast Amgen Inc. 4/22/2024 Aripiprazole Otsuka 11/14/2007 Asenapine Forest Labs 3/3/2015 Atazanavir  BMS 6/23/2015 Atezolizumab Genentech 9/22/2020 Axitinib Pfizer, Inc. 7/2/2024 Azelastine/Fluticasone and Azelastine Meda Pharmaceuticals 3/23/2015 Bendamustine Cephalon 5/24/2012 Bezlotoxumab Merck Sharpe and Dohme 5/12/2023 Bicalutamide AstraZeneca 9/19/2008 Bivalirudin The Medicines Company 6/17/2009 Blinatumomab Amgen 6/13/2023 Bosutinib PF Prism, C.V. 9/7/ 2023  Bortezomib  Millennium Pharmaceuticals 8/14/2015 Brentuximab vedotin Seagen, Inc. 11/18/2022 Brexpiprazole Otsuka Pharmaceutical Development & Commercialization 5/2/2024 Budesonide/Formoterol AstraZeneca
  1/25/2017
  Cabazitaxel Sanofi Aventis
  5/18/2017 Calcipotriene/Betamethasone Leo Pharma 7/15/2019 Canagliflozin Janssen Pharmaceuticals, Inc. 12/9/2024 Candesartan AstraZeneca Pharmaceuticals LP 7/20/2009 Capecitabine Hoffman-La Roche, Inc. 8/28/2013 Caspofungin Merck & Co., Inc. 4/15/2008 Cetirizine Nicox Ophthalmics  8/29/16  Clopidogrel Sanofi Aventis 1/20/2011 Cobimetinib Genentech, Inc. 7/19/2022 Colesevelam Daiichi Sankyo Pharma 2/17/2009 Crisaborole Pfizer 2/21/2020 Cysteamine Horizon 12/12/2017 Dabigatran Boehringer Ingelheim Pharmaceuticals, Inc. 2/12/2021 Dabrafenib Novartis  2/9/2023 Dapagliflozin AstraZeneca AB 5/30/2024 Darunavir Tibotec 6/7/2011 Deutetrabenazine  Teva Branded Pharmaceutical Products 5/5/2021

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Dexmedetomidine Hospira 3/12/2013 Difluprednate Alcon 3/21/2013 Docetaxel Sanofi Aventis 3/17/2010 Dulaglutide Eli Lilly and Company October 4, 2022 Duloxetine Eli Lilly 7/2/2012 Efavirenz BMS 1/29/2013 Eltrombopag  Novartis 8/14/2015 Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Gilead Sciences, Incorporated 9/13/2021 Empagliflozin/Empagliflozin and Metformin hydrochloride Boehringer Ingelheim Pharmaceuticals 6/9/2023 Entecavir BMS 12/5/2013 Eplerenone Pfizer 10/24/2007 Eribulin Mesylate Eisai, Inc. 8/9/2022 Erlotinib OSI Pharmaceuticals 3/18/2015 Esomeprazole AstraZeneca LP 5/1/2009 Eszopiclone Sunovion 6/29/2012 Etravirine  Janssen 6/21/2018 Everolimus Novartis 7/10/2012 Exenatide AstraZeneca 4/1/2021 Ezetimibe Schering Corporation 2/14/2008 Famciclovir Novartis 9/21/2009 Fenfluramine hydrochloride Zogenix, Inc  3/23/2022 Ferric Oxyhydroxide Vifor Fresenius Medical Care Renal Pharma France 6/1/2021 Fesoterodine Pfizer 6/3/2021 Fidaxomicin Cubist 12/13/2019 Finafloxacin Alcon 8/25/2014

Fingolimod  

 

Novartis 4/16/2018
  Fluticasone & Fluticasone/Salmeterol  Teva Pharmaceutical Industries Ltd. 6/10/2021 Fluticasone furoate vilanterol trifenatate GlaxoSmithKline 4/26/2023 Fosamprenavir ViiV Healthcare 1/10/2012 Fosaprepitant Merck  3/23/2018 Fulvestrant AstraZeneca 2/1/2011 Gatifloxacin Allergan 5/19/2009 Glecaprevir/Pibrentasvir AbbVie, Inc. 5/18/2021 Guanfacine Shire 10/17/2014

Halobetasol

Mayne Pharma LLC 5/21/2021 Ibrutinib  Pharmacyclics  8/8/2022 Ipilimumab BMS 7/20/17 Isavuconazonium sulfate Astellas Pharma US Inc. 11/29/2023 Ixabepilone  BMS 4/5/2011 Ivabradine   
  Amgen 3/30/2019 Lanadelumab Takeda Pharmaceuticals U.S.A., Inc. 12/20/2022 Lansoprazole Tap Pharmaceutical Products, Inc. 7/15/2008 Lenvatinib Mesylate Eisai Inc. 4/1/2024 Levetiracetam UCB, Inc. 6/3/2008 Levocetirizine UCB, Inc. 8/25/2009 Linagliptin/Linagliptin and metformin hydrochloride Boehringer Ingelheim Pharmaceuticals 6/9/2023 Liraglutide  Novo Nordisk 5/1/2019 Lisdexamfetamine  Takeda Pharmaceuticals USA, Inc.
  7/27/2021 Loteprednol/Tobramycin Bausch & Lomb 12/28/2010 Lopinavir/Ritonavir Abbott Laboratories 3/7/2008 Lumacaftor/Ivacaftor Vertex Pharmaceuticals Inc. 12/11/2024 Lurasidone Sunovion 12/20/2016 Lutetium Lu 177 dotatate Advanced Accelerator Applications 4/19/2024 Maraviroc ViiV Healthcare Co 7/29/2020 Memantine Forest Labs 6/16/2014 Methylphenidate
  Rhodes Pharmaceuticals 3/15/2019 Micafungin Astellas 11/14/2019 Mirabegron Astellas Pharma Global Development, Inc. 3/1/2021 Mometasone/formoterol Merck 6/24/2019 Nilotinib Novartis 3/20/2018 Nintedanib Boehringer Ingelheim Pharmaceuticals 10/6/2023 Nitric Oxide INO Therapeutics 11/2/2010 Nivolumab
    2/2/2023 Olmesartan Daiichi Sankyo 10/7/2009 Olopatadine Alcon Research, Ltd. 8/12/2009 Olopatadine Alcon Research, Ltd. 12/16/2014 Paclitaxel Abraxis 11/8/2019 Paliperidone Ortho-McNeil-Janssen Pharmaceuticals, Inc. 1/5/2011 Palonosetron Helsinn 4/10/2014 Pantoprazole Wyeth Pharmaceuticals, Inc. 2/17/2009 Pemetrexed Eli Lilly 12/3/2010 Phenylephrine/Ketorolac Omeros 12/6/2017 Pitavastatin   
  Kowa Research Institute] 3/30/2019 Pomalidomide Celgene Corporation 10/16/2020 Prasugrel   Eli Lilly 5/23/16 Quetiapine AstraZeneca Pharmaceuticals LP 1/23/2009 Rabeprazole Eisai 12/4/2012 Raltegravir Merck 8/14/2017 Remdesivir Gilead Sciences, Inc. January 23, 2024 Rilpivirine Janssen Products, LP. 1/18/2024 Risedronate Procter & Gamble Pharmaceuticals, Inc. 4/24/2009 Rivaroxaban  Janssen Pharmaceuticals, Inc. 11/23/2021 Rizatriptan Merck 9/20/2011 Rocuronium Organon, Inc. 4/3/2008 Rosuvastatin AstraZeneca Pharmaceuticals LP 7/7/2009 Rufinamide Eisai 1/13/2015 Ruxolitinib Incyte Corporation 12/1/2022 Sacubitril/Valsartan

Novartis

9/26/2019 Sapropterin BioMarin 3/13/2014 Saquinavir Hoffman-La Roche, Inc. 10/26/2010 Sildenafil Pfizer 2/9/2012 Sitagliptin Merck Sharp & Dohme Corp. 10/30/2020 Sofosbuvir Gilead Sciences, Inc. 7/23/2019 Sofosbuvir/Ledipasvir Gilead Sciences, Inc. 7/23/2019 Sofosbuvir/Velpatasvir
  Gilead Sciences, Inc. 5/13/2021 Solifenacin Astellas 7/20/2017 Sugammadex Merck, Sharp & Dohme LLC (Merck) 12/9/2024 Sumatriptan/Naproxen GlaxoSmithKline/Pernix 4/16/2015 Tadalafil   Eli Lilly  11/16/2017  Tamsulosin Boehringer Ingelheim 9/17/2009 Tapentadol Collegium Pharmaceutical Inc. June 11, 2024 Tavaborole Anacor 7/18/2018 Tbo-filgrastim Sicor
  7/18/2018 Technetium Tc99 sestamibi BMS 1/11/2008 Teduglutide  Shire – NPS Pharmaceuticals 
  3/7/2019 Temsirolimus Pfizer 2/28/2012 Tenofovir Gilead Sciences, Inc. 9/6/2011 Tenofovir
  Gilead Sciences, Inc. 11/15/2018

 

Teriflunomide Sanofi Aventis 3/31/2021 Ticagrelor AstraZeneca 4/8/2022 Tiotropium Boehringer Ingelheim Pharmaceuticals, Inc. 12/14/16 Tipranavir Boehringer Ingelheim Pharmaceuticals, Inc. 3/7/2008 Tocilizumab Genentech/Hoffmann-La Roche
  7/18/2018 Tofacitinib NEW Pfizer, Inc 02/19/2025 Topiramate Ortho-McNeil-Janssen Pharmaceuticals, Inc. 7/24/2008 Trabectedin Janssen 6/12/2018 Trametinib Novartis 2/9/2023 Valacyclovir GlaxoSmithKline 2/28/2008 Valganciclovir Hoffman-La Roche Inc. 7/24/2008 Valproate   Abbott 12/14/2007 Varenicline
  Pfizer 11/15/2018 Vigabatrin Lundbeck 10/3/2013 Vilazodone Allergan 1/21/2020 Vortioxetine Takeda Pharmaceuticals USA Inc. 8/21/2023 Zoledronic acid Novartis 12/21/2007

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