| DESCRIPTION | - Determining Whether to Submit an ANDA or a 505(b)(2) Application Guidance for Industry, U.S. Department of Health and Human Services, (20171000), pages 1 - 14 | - |
| DESCRIPTION | - Pharmaceutical Dosage Forms: Parenteral Medications, American Pharmaceutical Association and the Pharmaceutical Society, vol. 1-2 | - |
| DESCRIPTION | - Proceedings from the 6th World Symposium on Pulmonary Hypertension | - |
| DESCRIPTION | - BERGE, "Pharmaceutical Salts", J. Pharm. Sci., (19770000), vol. 66, doi:10.1002/jps.2600660104, pages 1 - 19, XP002675560 | |
| EXAMINATION | - Lajoie Annie-Christine ET AL, "Combination therapy in pulmonary arterial hypertension: recent accomplishments and future challenges", PULMONARY CIRCULATION 2012 APR-JUN, vol. 7, no. 2, doi:10.1177/2045893217710639, ISSN 2045-8940, (20170601), pages 312 - 325, URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5467950/pdf/10.1177_2045893217710639.pdf, XP055810165 | |
| OPPOSITION | - Actelion, "The Ecacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (TRITON) - NCT02558231", Clinical Trials, clinicaltrials.gov, (20190904), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02558231?term=NCT02558231&rank=1&a=9, XP093285396 | - |
| OPPOSITION | - Actelion, "The Ecacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (TRITON) - NCT02558231", Clinical Trials, clinicaltrials.gov, (20200826), Clinical Trials, URL: https://clinicaltrials.gov/study/NCT02558231?term=NCT02558231&rank=1&a=12, XP093285398 | - |
| OPPOSITION | - Anonymous, "Guideline on clinical development of fixed combination medicinal products (Revision 2)", European Medicines Agency (EMA); EMA/CHMP/158268/2017, Committee for Human Medicinal Products (CHMP), (20170323), European Medicines Agency (EMA); EMA/CHMP/158268/2017, Committee for Human Medicinal Products (CHMP), URL: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-development-fixed-combination-medicinal-products-revision-2_en.pdf, XP093285387 | - |
| OPPOSITION | - Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION - OPSUMIT® (macitentan) tablets, for oral use", (20131001), XP093261687 | - |
| OPPOSITION | - Anonymous, "New OPSUMIT (macitentan) Data Show Initial Combination Therapy with Tadalafil Improved Hemodynamic Clinical and Functional Parameters in Patients with Pulmonary Arterial Hypertension", Johnson & Johnson, (20191021), Johnson & Johnson, URL: https://www.jnj.com/media-center/press-releases/new-opsumit-macitentan-data-show-initial-combination-therapy-with-tadalafil-improved-hemodynamic-clinical-and-functional-parameters-in-patients-with-pulmonary-arterial-hypertension, XP093285383 | - |
| OPPOSITION | - Anonymous, " UPTRAVI ® (selexipag) tablets, for oral use - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20151201), FDA, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207947s000lbl.pdf, XP093285368 | - |
| OPPOSITION | - Besinque Gary M, Lickert Cassandra A, "The Myth of the Stable Pulmonary Arterial Hypertension Patient", Am J Manag Care, (20190301), vol. 25, no. 3, pages S47 - S52, XP093285353 | - |
| OPPOSITION | - D1a - Reference 48 of D1 | - |
| OPPOSITION | - D25 - https://news.thoracic.org/stat/05-06-20.php, webpage capture dated 18 January 2025, accessed via WayBack Machine | - |
| OPPOSITION | - D30 - Protocol for TM6, published as Supplementary Appendix | - |
| OPPOSITION | - FDA, "HIGHLIGHTS OF PRESCRIBING INFORMATION ADCIRCA", FDA.gov, (20090501), FDA.gov , URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022332lbl.pdf, (20161012), XP002762843 | - |
| OPPOSITION | - Jansa Pavel, Pulido Tomás, "Macitentan in Pulmonary Arterial Hypertension: A Focus on Combination Therapy in the SERAPHIN Trial", AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS, ADIS INTERNATIONAL,, NZ, NZ , (20180201), vol. 18, no. 1, doi:10.1007/s40256-017-0260-1, ISSN 1175-3277, pages 1 - 11, XP055852156 | |
| OPPOSITION | - Coghlan J. Gerry, Channick Richard, Chin Kelly, Di Scala Lilla, Galiè Nazzareno, Ghofrani Hossein-Ardeschir, Hoeper Marius M., Lang Irene M., Mclaughlin Vallerie, Preiss Ralph, Rubin Lewis J., Simonneau Gérald, Sitbon Olivier, Tapson Victor F., Gaine Sean, "Targeting the Prostacyclin Pathway with Selexipag in Patients with Pulmonary Arterial Hypertension Receiving Double Combination Therapy: Insights from the Randomized Controlled GRIPHON Study", AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS, ADIS INTERNATIONAL,, NZ, NZ , (20180201), vol. 18, no. 1, doi:10.1007/s40256-017-0262-z, ISSN 1175-3277, pages 37 - 47, XP093285355 | |
| OPPOSITION | - Burks Marsha, Stickel Simone, Galiè Nazzareno, "Pulmonary Arterial Hypertension: Combination Therapy in Practice", AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS, ADIS INTERNATIONAL,, NZ, NZ , (20180801), vol. 18, no. 4, doi:10.1007/s40256-018-0272-5, ISSN 1175-3277, pages 249 - 257, XP093285349 | |
| OPPOSITION | - Sitbon Olivier, Canuet Matthieu, Picard Francois, Gregoire Prevot, Bergot Emmanuel, Cottin Vincent, Bauer Fabrice, Degano Bruno, Gressin Virginie, Perchenet Loic, Clerson Pierre, Simonneau Gerald, "INITIAL TREATMENT COMBINATION WITH MACITENTAN AND TADALAFIL IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION: RESULTS FROM THE OPTIMA STUDY", CHEST Annual Meeting 2019, (20191019), vol. 156, doi:10.1016/j.chest.2019.08.825, pages A870 - A871, XP093285366 | |
| OPPOSITION | - McLaughlin Vallerie V.; Channick Richard; Chin Kelly; Frey Aline; Gaine Sean; Ghofrani Ardeschir; Hoeper Marius; Lang Irene; Preiss Ralph; Rubin Lewis J.; Simonneau Gérald; Sitbon Olivier; Stefani Mylène; Tapson Victor; Galiè Nazzareno , "EFFECT OF SELEXIPAG ON MORBIDITY/MORTALITY IN PULMONARY ARTERIAL HYPERTENSION: RESULTS OF THE GRIPHON STUDY", Journal of the American College of Cardiology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (19000101), vol. 65, no. 10, doi:10.1016/S0735-1097(15)61538-8, ISSN 0735-1097, XP029208198 | |
| OPPOSITION | - Sitbon Olivier, Channick Richard, Chin Kelly M., Frey Aline, Gaine Sean, Galiè Nazzareno, Ghofrani Hossein-Ardeschir, Hoeper Marius M., Lang Irene M., Preiss Ralph, Rubin Lewis J., Di Scala Lilla, Tapson Victor, Adzerikho Igor, Liu Jinming, Moiseeva Olga, Zeng Xiaofeng, Simonneau Gérald, Mclaughlin Vallerie V., "Selexipag for the Treatment of Pulmonary Arterial Hypertension", New England Journal of Medicine, (20151224), vol. 373, no. 26, doi:10.1056/NEJMoa1503184, ISSN 0028-4793, pages 2522 - 2533, XP093285400 | |
| OPPOSITION | - N Galie, O Sitbon, M Doelberg, J.S.R Gibbs, M.M Hoeper, N Martin, S.C Mathai, V McLaughlin, L Perchenet, G Simonneau, K Chin, "Long-term outcomes in newly diagnosed pulmonary arterial hypertension (PAH) patients receiving initial triple oral combination therapy: insights from the randomised controlled TRITON study", European Heart Journal: Acute Cardiovascular Care, SAGE Publications, (20201125), vol. 41, no. Suppl. 2, doi:10.1093/ehjci/ehaa946.2288, ISSN 2048-8726, page 2288, XP009561874 | |
| OPPOSITION | - Galiè Nazzareno, Humbert Marc, Vachiery Jean-Luc, Gibbs Simon, Lang Irene, Torbicki Adam, Simonneau Gérald, Peacock Andrew, Vonk Noordegraaf Anton, Beghetti Maurice, Ghofrani Ardeschir, Gomez Sanchez Miguel Angel, Hansmann Georg, Klepetko Walter, Lancellotti Patrizio, Matucci Marco, Mcdonagh Theresa, Pierard Luc A., Trindade Pedro T., Zompatori Maurizio, Hoeper Marius, "2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension : The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS)Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT)", European Heart Journal, Oxford University Press, GB, GB , (20160101), vol. 37, no. 1, doi:10.1093/eurheartj/ehv317, ISSN 0195-668X, pages 67 - 119, XP093285364 | |
| OPPOSITION | - Olivier Sitbon, Matthieu Canuet, François Picard, Gregoire Prevot, Emmanuel Bergot, Vincent Cottin, Fabrice Bauer, Bruno Degano, Virginie Gressin, Pierre Clerson, Gérald Simonneau, "Initial Combination Therapy with Macitentan and Tadalafil in Newly Diagnosed Patients with Pulmonary Arterial Hypertension: Results from the OPTIMA Trial", American Journal of Respiratory and Critical Care Medicine, (20170101), vol. 195, no. Suppl., doi:10.1164/ajrccm-conference.2017.195.1_MeetingAbstracts.A2297, ISSN 1073-449X, page A2297, XP009561870 | |
| OPPOSITION | - K.M. Chin, O. Sitbon, M. Doelberg, J.S.S.R. Gibbs, M.M. Hoeper, N. Martin, S.C. Mathai, V.V. McLaughlin, L. Perchenet, G. Simonneau, N. Galiè, "Efficacy and Safety of Initial Triple Oral Versus Initial Double Oral Combination Therapy in Patients with Newly Diagnosed Pulmonary Arterial Hypertension (PAH): Results of the Randomized Controlled TRITON Study", American Journal of Respiratory and Critical Care Medicine, (20200101), vol. 201, no. Suppl., doi:10.1164/ajrccm-conference.2020.201.1_MeetingAbstracts.A2928, ISSN 1073-449X, pages A2928 - A2928, XP009561869 | |
| OPPOSITION | - Belge Catharina, Delcroix Marion, "Treatment of pulmonary arterial hypertension with the dual endothelin receptor antagonist macitentan: clinical evidence and experience", Therapeutic advances in respiratory disease, Sage publications, (20190101), vol. 13, doi:10.1177/1753466618823440, ISSN 1753-4666, XP093285350 | |
| OPPOSITION | - Lajoie Annie-Christine, Bonnet Sebastien, Provencher Steeve, "Combination therapy in pulmonary arterial hypertension: recent accomplishments and future challenges", PULMONARY CIRCULATION 2012 APR-JUN, (20170601), vol. 7, no. 2, doi:10.1177/2045893217710639, ISSN 2045-8940, pages 312 - 325, XP055810165 | |
| OPPOSITION | - Sitbon Olivier, Jaïs Xavier, Savale Laurent, Cottin Vincent, Bergot Emmanuel, Macari Elise Artaud, Bouvaist Hélène, Dauphin Claire, Picard François, Bulifon Sophie, Montani David, Humbert Marc, Simonneau Gérald, "Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study", European Respiratory Journal, European Respiratory Society, (20140211), vol. 43, no. 6, doi:10.1183/09031936.00116313, ISSN 0903-1936, pages 1691 - 1697, XP093285358 | |
| OPPOSITION | - Sitbon Olivier, Sattler Caroline, Bertoletti Laurent, Savale Laurent, Cottin Vincent, Jaïs Xavier, De Groote Pascal, Chaouat Ari, Chabannes Céline, Bergot Emmanuel, Bouvaist Hélène, Dauphin Claire, Bourdin Arnaud, Bauer Fabrice, Montani David, Humbert Marc, Simonneau Gérald, "Initial dual oral combination therapy in pulmonary arterial hypertension", European Respiratory Journal, European Respiratory Society, (20160222), vol. 47, no. 6, doi:10.1183/13993003.02043-2015, ISSN 0903-1936, pages 1727 - 1736, XP093285357 | |
| OPPOSITION | - Sitbon Olivier, Gaine Sean, "Beyond a single pathway: combination therapy in pulmonary arterial hypertension", European Respiratory Review, European Respiratory Society, CH, CH , (20160930), vol. 25, no. 142, doi:10.1183/16000617.0085-2016, ISSN 0905-9180, pages 408 - 417, XP093285348 | |
| OPPOSITION | - Coghlan J Gerry, Picken Christina, Clapp Lucie H., "Selexipag in the management of pulmonary arterial hypertension: an update", Drug, Healthcare and Patient Safety, Volume 11, doi:10.2147/DHPS.S181313, pages 55 - 64, XP093043884 | |
