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'FDA Approvals'에 해당되는 글 25건
2015. 11. 7. 12:41

[2015-July-02] FDA approves new treatment for cystic fibrosis

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm453565.htm




Orkambi.cdx


Fredrick Van Goor, Sabine Hadida, Peter D. J. Grootenhuis, Bill Burton, Dong Cao, Tim Neuberger, Amanda Turnbull, Ashvani Singh, John Joubran, Anna Hazlewood, Jinglan Zhou, Jason McCartney, Vijayalaksmi Arumugam, Caroline Decker, Jennifer Yang, Chris Young, Eric R. Olson, Jeffery J. Wine, Raymond A. Frizzell, Melissa Ashlock and Paul Negulescu, Rescue of CF airway epithelial cell function in vitro by a CFTR potentiator, VX-770, Proc. Natl. Acad. Sci. U. S. A., 2009, 106 (44), pp 18825-18830

http://dx.doi.org/10.1073/pnas.0904709106


Fredrick Van Goor, Sabine Hadida, Peter D. J. Grootenhuis, Bill Burton, Jeffrey H. Stack, Kimberly S. Straley, Caroline J. Decker, Mark Miller, Jason McCartney, Eric R. Olson, Jeffrey J. Wine, Ray A. Frizzell, Melissa Ashlock, and Paul A. Negulescu, Correction of the F508del-CFTR protein processing defect in vitro by the investigational drug VX-809, Proc. Natl. Acad. Sci. U. S. A., 2011, 108 (46), pp 18843-18848

http://dx.doi.org/10.1073/pnas.1105787108


Steven M. Rowe, Stacey Miller, and Eric J. Sorscher, Cystic Fibrosis, N. Engl. J. Med., 2005352 (19), pp 1992-2001

http://dx.doi.org/10.1056/NEJMra043184


Pamela B. Davis, Cystic Fibrosis Since 1938, Am. J. Respir. Crit. Care Med., 2006, 173 (5), pp 475-482

http://dx.doi.org/10.1164/rccm.200505-840OE


William B. Guggino and Bruce A. Stanton, Mechanisms of disease: New insights into cystic fibrosis: molecular switches that regulate CFTR, Nat. Rev. Mol. Cell Biol., 2006, 7 (6), pp 426-436

http://dx.doi.org/10.1038/nrm1949


Zhi-wei Cai, Jia Liu, Hong-yu Li and David N. Sheppard, Targeting F508del-CFTR to develop rational new therapies for cystic fibrosis, Acta Pharmacol. Sin.201132 (6), pp 693–701

http://dx.doi.org/10.1038/aps.2011.71


Taylor Sitarik Cohen and Alice Prince, Cystic fibrosis: mucosal immunodeficiency syndrome, Nat. Med., 2012, 18 (4), pp 509–519

http://dx.doi.org/10.1038/nm.2715


Ruth O'Reilly and Heather E. Elphick, Development, clinical utility, and place of ivacaftor in the treatment of cystic fibrosis, Drug Des. Dev. Ther., 2013, (7), pp 929-937

http://dx.doi.org/10.2147/DDDT.S30345


2015. 9. 5. 20:11

[2015-June-22] FDA approves new antiplatelet drug used during heart procedure

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm452172.htm





Kengreal.cdx


Anthony H. Ingall, John Dixon, Andrew Bailey, Mandy E. Coombs, David Cox, Judith I. McInally, Simon F. Hunt, Nicholas D. Kindon, Barry J. Teobald, Paul A. Willis, Robert G. Humphries, Paul Leff, Jane A. Clegg, James A. Smith, and Wendy Tomlinson, Antagonists of the platelet P2T receptor:  a novel approach to antithrombotic therapy, J. Med. Chem., 1999, 42 (2), pp 213–220

http://dx.doi.org/10.1021/jm981072s


Nicholas B. Norgard, Cangrelor: a novel P2Y12 receptor antagonist, Expert Opin. Investig. Drugs200918 (8), pp 1219-1230

http://dx.doi.org/10.1517/13543780903136708


Shawn M. Bauer, ADP receptor antagonists as antiplatelet therapeutics, Expert Opin. Emerging Drugs20038 (1), pp 93-101

http://dx.doi.org/10.1517/14728214.8.1.93


Satya P. Kunapuli, Zhongren Ding, Robert T. Dorsam, Soochong Kim, Swaminathan Murugappan, and Todd M. Quinton, ADP receptors-targets for developing antithrombotic agents, Curr. Pharm. Design, 2003, 9 (14), pp 2303-2316

http://dx.doi.org/10.2174/1381612033453947


Alan D. Michelson, Antiplatelet therapies for the treatment of cardiovascular disease, Nat. Rev. Drug Discov.20109 (2), pp 154-169

http://dx.doi.org/10.1038/nrd2957


S. M. A. Fayaz and G. K. Rajanikant, A critical appraisal of the functional evolution of P2Y12 antagonists as antiplatelet Drugs, Curr. Pharm. Design, 2012, 18 (12), pp 1625-1634

http://dx.doi.org/10.2174/138161212799958558


Maria Lukasik and Michal K. Owecki, Efficacy of antiplatelet treatment in stroke prevention: past, present, and future, Drug Dev. Res.201374 (7), pp 428–439

http://dx.doi.org/10.1002/ddr.21100


Nicola Ferri, Alberto Corsini, and Stefano Bellosta, Pharmacology of the new P2Y12 receptor inhibitors: insights on pharmacokinetic and pharmacodynamic properties, Drugs201373 (15), pp 1681-1709

http://dx.doi.org/10.1007/s40265-013-0126-z


Elisabetta Liverani, Laurie E. Kilpatrick, Alexander Y. Tsygankov and Satya P. Kunapuli, The role of P2Y12 receptor and activated platelets during inflammation, Curr. Drug Targets, 2014, 15 (7), pp 720-728

http://dx.doi.org/10.2174/1389450115666140519162133


Kritika Chaudhari, Bashar Hamad, and Basharut A. Syed, Antithrombotic drugs market, Nat. Rev. Drug Discov., 201413 (8), pp 571–572

http://dx.doi.org/10.1038/nrd4365

2015. 8. 29. 16:32

[2015-May-27] FDA approves two therapies to treat IBS-D

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm448328.htm





Viberzi.cdx


Henry J. Breslin, Craig J. Diamond, Robert W. Kavash, Chaozhong Cai, Alexey B. Dyatkin, Tamara A. Miskowski, Sui-Po Zhang, Paul R. Wade, Pamela J. Hornby, and Wei He, Identification of a dual δ OR antagonist/μ OR agonist as a potential therapeutic for diarrhea-predominant Irritable Bowel Syndrome (IBS-d), Bioorg. Med. Chem. Lett., 2012, 22 (14), pp 4869-4872

http://dx.doi.org/10.1016/j.bmcl.2012.05.042


Roberto De Giorgio, Giovanni Barbara, John B. Furness, and Marcello Tonini, Novel therapeutic targets for enteric nervous system disorders, Trends Pharmacol. Sci., 2007, 28 (9), pp 473-481

http://dx.doi.org/10.1016/j.tips.2007.08.003


Sylvie Bradesi, and Emeran A Mayer, Novel therapeutic approaches in IBS, Curr. Opin. Pharmacol., 2007, 7 (6), pp 598–604

http://dx.doi.org/10.1016/j.coph.2007.09.012


Michael Camilleri, Drug development and IBS drugs: experience from the past, current challenges, and proposal for the future, Curr. Opin. Pharmacol.20088 (6), pp 671–676

http://dx.doi.org/10.1016/j.coph.2008.06.001


Howard Y. Chang, and Anthony J. Lembo, Opioid-induced bowel dysfunction, Curr. Treat. Options Gastroenterol., 2008, 11 (1)pp 11-18

http://dx.doi.org/10.1007/s11938-008-0002-1


Joseph Y. Chang, and Nicholas J. Talley, Current and emerging therapies in irritable bowel syndrome: from pathophysiology to treatment, Trends Pharmacol. Sci.201031 (7), pp 326–334

http://dx.doi.org/10.1016/j.tips.2010.04.008


Michael Camilleri, Peripheral Mechanisms in Irritable Bowel Syndrome, N. Engl. J. Med., 2012, 367 (17), pp 1626-1635

http://dx.doi.org/10.1056/NEJMra1207068


Michael Camilleri, Current and future pharmacological treatments for diarrhea-predominant irritable bowel syndrome, Expert Opin. Pharmacol., 2013, 14 (9), pp 1151-1160

http://dx.doi.org/10.1517/14656566.2013.794223


Jose L. Barboza, Nicholas J. Talley, and Baharak Moshiree, Current and Emerging Pharmacotherapeutic Options for Irritable Bowel Syndrome, Drugs, 2014, 74 (16), pp 1849-1870

http://dx.doi.org/10.1007/s40265-014-0292-7


2015. 8. 23. 15:38

[2015-May-21] FDA approves Stiolto™* Respimat® as once-daily maintenance treatment for COPD

https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/26_may_2015_copd.html





Stiolto_Respimat.cdx


Bernd Disse, Richard Reichl, Georg Speck, Werner Traunecker, Karl Ludwig Rominger, and Rudolf Hammer, Ba 679 BR, A novel long-acting anticholinergic bronchodilator, Life Sci., 1993, 52 (5-6), pp 537-544

http://dx.doi.org/10.1016/0024-3205(93)90312-Q


Bernd Disse, Georg A. Speck, Karl Ludwig Rominger, Theodore J. Witek Jr., and Rudolf Hammer, Tiotropium (SPIRIVA™): Mechanistical considerations and clinical profile in obstructive lung disease, Life Sci.1999, 64 (6-7), pp 457-464

http://dx.doi.org/10.1016/S0024-3205(98)00588-8


Thierry Bouyssou, Christoph Hoenke, Klaus Rudolf, Philipp Lustenberger, Sabine Pestel, Peter Sieger, Ralf Lotz, Claudia Heine, Frank H. Büttner, Andreas Schnapp, and Ingo Konetzki, Discovery of olodaterol, a novel inhaled β2-adrenoceptor agonist with a 24 h bronchodilatory efficacy, Bioorg. Med. Chem. Lett., 2010, 20 (4)pp 1410–1414

http://dx.doi.org/10.1016/j.bmcl.2009.12.087


T. Bouyssou, P. Casarosa, E. Naline, S. Pestel, I. Konetzki, P. Devillier, and A. Schnapp, Pharmacological Characterization of Olodaterol, a Novel Inhaled β2-Adrenoceptor Agonist Exerting a 24-Hour-Long Duration of Action in Preclinical Models, J. Pharmacol. Exp. Ther., 2010, 334 (1), pp 53-62

http://dx.doi.org/10.1124/jpet.110.167007


Mario Cazzola, and Mathieu Molimard, The scientific rationale for combining long-acting β2-agonists and muscarinic antagonists in COPD, Pulm. Pharmacol. Ther., 201023 (4), pp 257–267

http://dx.doi.org/10.1016/j.pupt.2010.03.003


Mario Cazzola Luigino Calzetta and Maria Gabriella Matera, β2-adrenoceptor agonists: current and future direction, British J. Pharmacol., 2011, 163 (1), pp 4-17

http://dx.doi.org/10.1111/j.1476-5381.2011.01216.x


Yasser Mushtaq, The COPD pipeline, Nat. Rev. Drug Discov., 201413 (4), pp 253–254

http://dx.doi.org/10.1038/nrd4254


Andrew C. Kruse, Brian K. Kobilka, Dinesh Gautam, Patrick M. Sexton, Arthur Christopoulos and Jürgen Wess, Muscarinic acetylcholine receptors: novel opportunities for drug development, Nat. Rev. Drug Discov., 201413 (7), pp 549–560

http://dx.doi.org/10.1038/nrd4295


Paolo Montuschi and Giovanni Ciabattoni, Bronchodilating Drugs for Chronic Obstructive Pulmonary Disease: Current Status and Future Trends, J. Med. Chem., 2015, 58 (10), pp 4131–4164

http://dx.doi.org/10.1021/jm5013227


2015. 8. 15. 17:19

[2015-Apr-15] FDA approves Corlanor to treat heart failure

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm442978.htm





Corlanor.cdx


S.M. Gardiner, P.A. Kemp, J.E. March and T. Bennett, Acute and chronic cardiac and regional haemodynamic effects of the novel bradycardic agent, S16257, in conscious rats, British J Pharmacol., 1995, 115 (4), pp 579-586

http://dx.doi.org/10.1111/j.1476-5381.1995.tb14971.x


Irina Savelieva and A. John Camm, If Inhibition with Ivabradine, Drug Saf., 2008, 31 (2), pp 95-107

http://dx.doi.org/10.2165/00002018-200831020-00001


Andrea Rognoni, Marzia Bertolazzi, Sergio Maccio and Giorgio Rognoni, Ivabradine: Cardiovascular Effects, Recent Pat. Cardiovasc. Drug Discov., 2009, 4 (1), pp 61-66

http://dx.doi.org/10.2174/157489009787260016#sthash.3Q3jPmHe.dpuf

2015. 3. 8. 15:34

[2015-Mar-06] FDA approves new antifungal drug Cresemba

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm437106.htm




Cresemba.cdx


Peter A. Warn, Andrew Sharp and David W. Denning, In vitro activity of a new triazole BAL4815, the active component of BAL8557 (the water-soluble prodrug), against Aspergillus spp., J. Antimicrob. Chemother., 2006, 57 (1), pp 135-138

http://dx.doi.org/10.1093/jac/dki399


Anne Schmitt-Hoffmann, Brigitte Roos, Jürgen Maares, Markus Heep, Jochen Spickerman,

Erhard Weidekamm, Tom Brown and Michael Roehrle, Multiple-Dose Pharmacokinetics and Safety of the New Antifungal Triazole BAL4815 after Intravenous Infusion and Oral Administration of Its Prodrug, BAL8557, in Healthy Volunteers, Antimicrob. Agents Chemother., 2006, 50 (1), pp 286-293

http://dx.doi.org/10.1128/AAC.50.1.286-293.2006


H. Seifert, U. Aurbach, D. Stefanik and O. Cornely, In Vitro Activities of Isavuconazole and Other Antifungal Agents against Candida Bloodstream Isolates, Antimicrob. Agents Chemother., 2007, 51 (5), pp 1818-1821

http://dx.doi.org/10.1128/AAC.01217-06


A. C. Pasqualotto and D. W. Denning, New and emerging treatments for fungal infections, J. Antimicrob. Chemother.200861 (suppl. 1), pp i19-i30

http:/dx.doi.org/10.1093/jac/dkm428


Corrado Girmenia, New generation azole antifungals in clinical investigation, Expert Opin. Investig. Drugs, 2009, 18 (9)pp 1279-1295

http://dx.doi.org/10.1517/13543780903176407

2015. 3. 1. 12:52

[2015-Feb-25] FDA approves new antibacterial drug Avycaz

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm435629.htm


Avycaz.cdx


Ludo Verbist and Jan Verhaegen, GR-20263: a new aminothiazolyl cephalosporin with high activity against Pseudomonas and Enterobacteriaceae, Antimicrob. Agents Chemother., 1980, 17 (5), pp 807-812

http://dx.doi.org/10.1128/AAC.17.5.807


Ken Coleman, Diazabicyclooctanes (DBOs): a potent new class of non-β-lactam β-lactamase inhibitors, Curr. Opin. Microbiol., 2011, 14 (5), pp 550-555

http://dx.doi.org/10.1016/j.mib.2011.07.026


Z. Aktaş, C. Kayacan and O. Oncul, In vitro activity of avibactam (NXL104) in combination with β-lactams against Gram-negative bacteria, including OXA-48 β-lactamase-producing Klebsiella pneumoniae, Int. J. Antimicrob. Agents, 201239 (1), pp 86-89

http://dx.doi.org/10.1016/j.ijantimicag.2011.09.012


George G. Zhanel, Christopher D. Lawson, Heather Adam, Frank Schweizer, Sheryl Zelenitsky, Philippe R. S. Lagacé-Wiens, Andrew Denisuik, Ethan Rubinstein, Alfred S. Gin, Daryl J. Hoban, Joseph P. Lynch 3rd and James A. Karlowsky, Ceftazidime-Avibactam: a Novel Cephalosporin/β-lactamase Inhibitor Combination, Drugs, 2013, 73 (2), pp 159-177

http://dx.doi.org//10.1007/s40265-013-0013-7

2015. 2. 28. 22:33

[2015-Feb-23] FDA approves Farydak for treatment of multiple myeloma

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm435296.htm




Farydak.cdx


M. Cecilia Crisanti, Africa F. Wallace, Veena Kapoor, Fabian Vandermeers, Melissa L. Dowling, Luana P. Pereira, Kara Coleman, Barbara G. Campling, Zvi G. Fridlender, Gary D. Kao and Steven M. Albelda, The HDAC inhibitor panobinostat (LBH589) inhibits mesothelioma and lung cancer cells in vitro and in vivo with particular efficacy for small cell lung cancer, Mol. Cancer Ther., 2009, 8 (8), pp 2221-2231

http://dx.doi.org/10.1158/1535-7163.MCT-09-0138


Jessica E. Bolden, Melissa J. Peart and Ricky W. Johnstone, Anticancer activities of histone deacetylase inhibitors, Nat. Rev. Drug Discov., 20065 (9), pp 769-784

http://dx.doi.org/10.1038/nrd2133

2015. 2. 28. 17:48

[2015-Jan-29] HIV/AIDS Update - Prezcobix tablet containing 800 mg of darunavir and 150 mg of cobicistat approval

http://content.govdelivery.com/accounts/USFDA/bulletins/ed4466




Prezcobix.cdx

Arun K Ghosh, John F Kincaid, Wonhwa Cho, D.Eric Walters, K Krishnan, Khaja Azhar Hussain, Yumee Koo, Hanna Cho, Clare Rudall, Louis Holland and Jim Buthod, Potent HIV protease inhibitors incorporating high-affinity P2-ligands and (R)-(hydroxyethylamino)sulfonamide isostere, Bioorg. Med. Chem. Lett., 1998, 8 (6), pp 687-690

http://dx.doi.org/10.1016/S0960-894X(98)00098-5


Sandra De Meyer, Hilde Azijn, Dominique Surleraux, Dirk Jochmans, Abdellah Tahri, Rudi Pauwels, Piet Wigerinck and Marie-Pierre de Béthune, TMC114, a Novel Human Immunodeficiency Virus Type 1 Protease Inhibitor Active against Protease Inhibitor-Resistant Viruses, Including a Broad Range of Clinical Isolates, Antimicrob. Agents Chemother.200549 (6), pp 2314-2321

http://dx.doi.org/10.1128/AAC.49.6.2314-2321.2005


Bonaventura Clotet, Nicholas Bellos,Jean-Michel Molina, David Cooper, Jean-Christophe Goff ard, Adriano Lazzarin, Andrej Wöhrmann, Christine Katlama, Timothy Wilkin, Richard Haubrich, Calvin Cohen, Charles Farthing, Dushyantha Jayaweera, Martin Markowitz, Peter Ruane, Sabrina Spinosa-Guzman, Eric Lefebvre,on behalf of the POWER 1 and 2 study groups, Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials, Lancet, 2007369 (9568), pp 1169-1178

http://dx.doi.org/10.1016/S0140-6736(07)60497-8


Lianhong Xu, Hongtao Liu, Bernard P. Murray, Christian Callebaut, Melody S. Lee, Allen Hong, Robert G. Strickley, Luong K. Tsai, Kirsten M. Stray, Yujin Wang, Gerry R. Rhodes and Manoj C. Desai, Cobicistat (GS-9350): A Potent and Selective Inhibitor of Human CYP3A as a Novel Pharmacoenhancer, ACS Med. Chem. Lett., 2010, 1 (5), pp 209–213

http://dx.doi.org/10.1021/ml1000257


Eve-Irene Lepist, Truc K. Phan, Anupma Roy, Leah Tong, Kelly MacLennan, Bernard Murray and Adrian S. Ray, Cobicistat Boosts the Intestinal Absorption of Transport Substrates, Including HIV Protease Inhibitors and GS-7340, In Vitro, Antimicrob. Agents Chemother., 2012, 56 (10), pp 5409-5413

http://dx.doi.org/10.1128/AAC.01089-12

2015. 2. 28. 14:35

[2015-Jan-29] HIV/AIDS Update - Approval of Evotaz, containing 300 mg of atazanavir and 150 mg of cobicistat

http://content.govdelivery.com/accounts/USFDA/bulletins/ed4095



Evotaz.cdx


Brett S. Robinson, Keith A. Riccardi, Yi-fei Gong, Qi Guo, David A. Stock, Wade S. Blair, Brian J. Terry, Carol A. Deminie, Fred Djang, Richard J. Colonno, and Pin-fang Lin, BMS-232632, a Highly Potent Human Immunodeficiency Virus Protease Inhibitor That Can Be Used in Combination with Other Available Antiretroviral Agents, Antimicrob. Agents Chemother., 2000, 44 (8), pp 2093-2099

http://dx.doi.org/10.1128/AAC.44.8.2093-2099.2000


Katherine F. Croom, Sohita Dhillon, and Susan J. Keam, Atazanavir, Drugs2009, 69 (8), pp 1107-1140

http://dx.doi.org/10.2165/00003495-200969080-00009


Lianhong Xu, Hongtao Liu, Bernard P. Murray, Christian Callebaut, Melody S. Lee, Allen Hong, Robert G. Strickley, Luong K. Tsai, Kirsten M. Stray, Yujin Wang, Gerry R. Rhodes and Manoj C. Desai, Cobicistat (GS-9350): A Potent and Selective Inhibitor of Human CYP3A as a Novel Pharmacoenhancer, ACS Med. Chem. Lett., 2010, 1 (5), pp 209–213

http://dx.doi.org/10.1021/ml1000257


Eve-Irene Lepist, Truc K. Phan, Anupma Roy, Leah Tong, Kelly MacLennan, Bernard Murray and Adrian S. Ray, Cobicistat Boosts the Intestinal Absorption of Transport Substrates, Including HIV Protease Inhibitors and GS-7340, In Vitro, Antimicrob. Agents Chemother., 2012, 56 (10), pp 5409-5413

http://dx.doi.org/10.1128/AAC.01089-12

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