{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T00:30:56Z","timestamp":1791592256156,"version":"4.3.4"},"reference-count":65,"publisher":"Public Library of Science (PLoS)","issue":"10","license":[{"start":{"date-parts":[[2018,10,16]],"date-time":"2018-10-16T00:00:00Z","timestamp":1539648000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"DOI":"10.1371\/journal.pone.0205166","type":"journal-article","created":{"date-parts":[[2018,10,16]],"date-time":"2018-10-16T17:44:17Z","timestamp":1539711857000},"page":"e0205166","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":59,"title":["Introduction and geographic availability of new antibiotics approved between 1999 and 2014"],"prefix":"10.1371","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1078-3128","authenticated-orcid":true,"given":"Cecilia","family":"K\u00e5llberg","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"\u00c5rdal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hege","family":"Salvesen Blix","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eili","family":"Klein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"M. Martinez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morten","family":"Lindb\u00e6k","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Outterson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John-Arne","family":"R\u00f8ttingen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramanan","family":"Laxminarayan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2018,10,16]]},"reference":[{"issue":"12","key":"ref1","doi-asserted-by":"crossref","first-page":"1057","DOI":"10.1016\/S1473-3099(13)70318-9","article-title":"Antibiotic resistance\u2014the need for global solutions","volume":"13","author":"R Laxminarayan","year":"2013","journal-title":"The Lancet infectious diseases"},{"key":"ref2","unstructured":"World Health Organization (WHO). Global action plan on antimicrobial resistance 2015 [Cited: 04 Oct 2018]. Available from: http:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/193736\/9789241509763_eng.pdf?sequence=1<\/ext-link>."},{"issue":"5","key":"ref3","doi-asserted-by":"crossref","first-page":"363","DOI":"10.7326\/M16-0291","article-title":"Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of US Food and Drug Administration\u2013Approved Antibiotics, 2010\u20132015FDA-Approved Antibiotics, 2010\u20132015","volume":"165","author":"D Deak","year":"2016","journal-title":"Annals of internal medicine"},{"key":"ref4","article-title":"Targeting innovation in antibiotic drug discovery and development","author":"MJ Renwick","year":"2016","journal-title":"Health Policy Series of the European Observatory on Health Systems and Policies"},{"issue":"2","key":"ref5","doi-asserted-by":"crossref","first-page":"176","DOI":"10.3109\/03009734.2014.898717","article-title":"New business models for antibiotic innovation","volume":"119","author":"AD So","year":"2014","journal-title":"Upsala journal of medical sciences"},{"key":"ref6","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.c2115","article-title":"Stoking the antibiotic pipeline","volume":"340","author":"CM Morel","year":"2010","journal-title":"BMJ: British Medical Journal (Online)"},{"issue":"2","key":"ref7","doi-asserted-by":"crossref","first-page":"277","DOI":"10.1377\/hlthaff.2014.1003","article-title":"Repairing the broken market for antibiotic innovation","volume":"34","author":"K Outterson","year":"2015","journal-title":"Health affairs"},{"issue":"2","key":"ref8","doi-asserted-by":"crossref","first-page":"118","DOI":"10.1016\/j.drup.2011.02.003","article-title":"Critical shortage of new antibiotics in development against multidrug-resistant bacteria\u2014Time to react is now","volume":"14","author":"L Freire-Moran","year":"2011","journal-title":"Drug resistance updates"},{"issue":"9","key":"ref9","doi-asserted-by":"crossref","first-page":"1283","DOI":"10.1016\/j.drudis.2014.07.005","article-title":"An analysis of FDA-approved drugs for infectious disease: antibacterial agents","volume":"19","author":"MS Kinch","year":"2014","journal-title":"Drug discovery today"},{"key":"ref10","unstructured":"ECDC\/EMEA Joint Working Group. The bacterial challenge: time to react 2009 [Cited: 04 Oct 2018]. 13\u201342]. Available from: https:\/\/www.ema.europa.eu\/documents\/report\/bacterial-challenge-time-react_en.pdf<\/ext-link>."},{"key":"ref11","unstructured":"World Health Organization. Antibacterial Agents in Clinical Development 2017 [Cited: 04 Oct 2018]. Available from: http:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/258965\/WHO-EMP-IAU-2017.11-eng.pdf?sequence=1<\/ext-link>."},{"key":"ref12","unstructured":"O\u2019Neill J. Tackling drug-resistant infections globally: Final report and recommendations. 2016 2018 [Cited: 04 Oct 2018]. Available from: https:\/\/amr-review.org\/Publications.html<\/ext-link>."},{"issue":"9","key":"ref13","doi-asserted-by":"crossref","first-page":"1941","DOI":"10.1093\/jac\/dkr262","article-title":"Discovery research: the scientific challenge of finding new antibiotics","volume":"66","author":"DM Livermore","year":"2011","journal-title":"Journal of antimicrobial chemotherapy"},{"issue":"4","key":"ref14","doi-asserted-by":"crossref","first-page":"331","DOI":"10.1080\/19466315.2015.1094406","article-title":"Comment: fundamentals and innovation in antibiotic trials.","volume":"7","author":"SR Evans","year":"2015","journal-title":"Statistics in biopharmaceutical research"},{"issue":"11","key":"ref15","doi-asserted-by":"crossref","first-page":"403","DOI":"10.3345\/kjp.2012.55.11.403","article-title":"Understanding noninferiority trials","volume":"55","author":"S Hahn","year":"2012","journal-title":"Korean journal of pediatrics"},{"issue":"5","key":"ref16","doi-asserted-by":"crossref","first-page":"1281","DOI":"10.1093\/jac\/dku572","article-title":"Antibiotics: the changing regulatory and pharmaceutical industry paradigm","volume":"70","author":"R Bax","year":"2015","journal-title":"Journal of Antimicrobial Chemotherapy"},{"key":"ref17","unstructured":"O'Niell J. Securing New Drugs for Future Generations\u2013the Pipeline of Antibiotics. 2015 [Cited: 04 Oct 2018]. Available from: https:\/\/amr-review.org\/sites\/default\/files\/SECURING%20NEW%20DRUGS%20FOR%20FUTURE%20GENERATIONS%20FINAL%20WEB_0.pdf<\/ext-link>."},{"issue":"10","key":"ref18","doi-asserted-by":"crossref","first-page":"6605","DOI":"10.1128\/AAC.01165-15","article-title":"First report of ceftazidime-avibactam resistance in a KPC-3-expressing Klebsiella pneumoniae isolate","volume":"59","author":"RM Humphries","year":"2015","journal-title":"Antimicrobial agents and chemotherapy"},{"issue":"4","key":"ref19","doi-asserted-by":"crossref","first-page":"500","DOI":"10.1016\/S1473-3099(15)00500-9","article-title":"Antibiotic reimbursement in a model delinked from sales: a benchmark-based worldwide approach","volume":"16","author":"JH Rex","year":"2016","journal-title":"The Lancet Infectious Diseases"},{"key":"ref20","article-title":"Breaking through the wall: a call for concerted action on antibiotics research and development","author":"S Stern","year":"2017","journal-title":"Breaking through the wall: a call for concerted action on antibiotics research and development"},{"key":"ref21","article-title":"Revitalizing the antibiotic pipeline: Stimulating innovation while driving sustainable use and global access","author":"CO \u00c5rdal","year":"2018","journal-title":"Revitalizing the antibiotic pipeline: Stimulating innovation while driving sustainable use and global access"},{"issue":"8","key":"ref22","doi-asserted-by":"crossref","first-page":"1091","DOI":"10.1086\/512810","article-title":"Group ESoACP. Comparison of outpatient systemic antibacterial use in 2004 in the United States and 27 European countries","volume":"44","author":"H Goossens","year":"2007","journal-title":"Clinical infectious diseases"},{"issue":"8","key":"ref23","doi-asserted-by":"crossref","first-page":"742","DOI":"10.1016\/S1473-3099(14)70780-7","article-title":"Global antibiotic consumption 2000 to 2010: an analysis of national pharmaceutical sales data","volume":"14","author":"TP Van Boeckel","year":"2014","journal-title":"The Lancet Infectious Diseases"},{"issue":"9271","key":"ref24","doi-asserted-by":"crossref","first-page":"1851","DOI":"10.1016\/S0140-6736(00)04972-2","article-title":"Variation in antibiotic use in the European Union","volume":"357","author":"O Cars","year":"2001","journal-title":"The Lancet"},{"issue":"2","key":"ref25","doi-asserted-by":"crossref","first-page":"89","DOI":"10.1097\/00004479-200404000-00003","article-title":"Overview of the European regulatory approval system","volume":"27","author":"F Pignatti","year":"2004","journal-title":"The Journal of ambulatory care management"},{"issue":"3","key":"ref26","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1016\/S0924-8579(00)00229-6","article-title":"Licensing new antibacterial agents\u2014a European perspective","volume":"16","author":"M Powell","year":"2000","journal-title":"International journal of antimicrobial agents"},{"issue":"3","key":"ref27","first-page":"289","article-title":"Approval of new drugs 1999\u20132007: comparison of the US, the EU and Japan situations","volume":"35","author":"K Tsuji","year":"2010","journal-title":"Journal of clinical pharmacy and therapeutics"},{"issue":"24","key":"ref28","doi-asserted-by":"crossref","first-page":"2284","DOI":"10.1056\/NEJMsa1200223","article-title":"Regulatory review of novel therapeutics\u2014comparison of three regulatory agencies","volume":"366","author":"NS Downing","year":"2012","journal-title":"New England Journal of Medicine"},{"key":"ref29","unstructured":"European Medicines Agency [Internet]. Medicines [Cited: 04 Oct 2018]. Available from: https:\/\/www.ema.europa.eu\/en\/medicines<\/ext-link>."},{"key":"ref30","unstructured":"U.S. Food and Drug Administration [Internet]. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) [Cited: 04 Oct 2018]. Available from: https:\/\/www.fda.gov\/Drugs\/InformationOnDrugs\/ucm129662.htm<\/ext-link>."},{"key":"ref31","unstructured":"Pharmaceuticals and Medical Devices Agency [Internet]. List of Approved Products [Cited: 04 Oct 2018]. Available from: https:\/\/www.pmda.go.jp\/english\/review-services\/reviews\/approved-information\/drugs\/0002.html#<\/ext-link>."},{"key":"ref32","unstructured":"Central Drugs Standard Control Organization [Internet]. List of approved new drugs [Cited: 04 Oct 2018]. Available from: http:\/\/www.cdsco.nic.in\/forms\/list.aspx?lid=2034&Id=11<\/ext-link>."},{"key":"ref33","unstructured":"WHO Collaborating Centre for Drug Statistics Methodology [Internet]. Structure and principles [Cited: 04 Oct 2018]. Available from: https:\/\/www.whocc.no\/atc_ddd_index\/<\/ext-link>."},{"key":"ref34","unstructured":"WHO Collaborating Centre for Drug Statistics Methodology [Internet]. International language for drug utilization research [Cited: 04 Oct 2018]. Available from: https:\/\/www.whocc.no\/<\/ext-link>."},{"issue":"1","key":"ref35","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1038\/ja.2016.72","article-title":"Antibiotics in the clinical pipeline at the end of 2015","volume":"70","author":"MS Butler","year":"2016","journal-title":"The Journal of Antibiotics"},{"key":"ref36","unstructured":"U.S. Food and Drug Administration [Internet]. Drugs@FDA: FDA Approved Drug Products [Cited: 04 Oct 2018]. Available from: https:\/\/www.accessdata.fda.gov\/scripts\/cder\/daf\/index.cfm<\/ext-link>."},{"key":"ref37","unstructured":"Swedish Medical Product Agency [Internet]. L\u00e4kemedelsverket [Cited: 04 Oct 2018]. Available from: https:\/\/lakemedelsverket.se\/english\/<\/ext-link>."},{"key":"ref38","unstructured":"Datapharm [Internet]. Electronic Medicines Compendium, [Cited: 04 Oct 2018]. Available from: https:\/\/www.medicines.org.uk\/emc\/<\/ext-link>."},{"key":"ref39","unstructured":"Government of Canada [Internet]. Drug Product Database: Access the database [Cited: 04 Oct 2018]. Available from: https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/drug-products\/drug-product-database.html<\/ext-link>."},{"key":"ref40","unstructured":"WHO Collaborating Centre for Drug Statistics Methodology [Internet]. ATC\/DDD Index 2017 [Cited: 04 Oct 2018]. Available from: https:\/\/www.whocc.no\/atc_ddd_index\/<\/ext-link>."},{"key":"ref41","unstructured":"National Institutes of Health [Internet]. LiverTox [Cited: 04 Oct 2018]. Available from: https:\/\/livertox.nlm.nih.gov\/<\/ext-link>."},{"key":"ref42","unstructured":"Springer [Internet]. Adis Insight Database [Cited: 04 Oct 2018]. Available from: http:\/\/adisinsight.springer.com\/<\/ext-link>."},{"key":"ref43","doi-asserted-by":"crossref","first-page":"293","DOI":"10.1016\/S0065-7743(01)36068-2","article-title":"Chapter 28. To market, to market\u20142000","volume":"36","author":"B Gaudilliere","year":"2001","journal-title":"Annual Reports in Medicinal Chemistry"},{"key":"ref44","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1016\/S0065-7743(02)37027-1","article-title":"Chapter 26. To market, to market\u20142001","volume":"37","author":"P Bernardelli","year":"2002","journal-title":"Annual Reports in Medicinal Chemistry"},{"key":"ref45","doi-asserted-by":"crossref","first-page":"347","DOI":"10.1016\/S0065-7743(03)38034-0","article-title":"Chapter 33. To market, to market\u20142002","volume":"38","author":"C Boyer-Joubert","year":"2003","journal-title":"Annual Reports in Medicinal Chemistry"},{"key":"ref46","doi-asserted-by":"crossref","first-page":"335","DOI":"10.1016\/S0065-7743(04)39025-1","article-title":"To Market, To Market\u20142003","volume":"39","author":"S Hegde","year":"2004","journal-title":"Annual Reports in Medicinal Chemistry"},{"key":"ref47","doi-asserted-by":"crossref","first-page":"443","DOI":"10.1016\/S0065-7743(05)40029-9","article-title":"To Market, To Market\u20142004","volume":"40","author":"S Hegde","year":"2005","journal-title":"Annual Reports in Medicinal Chemistry"},{"key":"ref48","first-page":"439","article-title":"Annual Reports in Medicinal Chemistry","volume":"41","author":"S Hegde","year":"2006"},{"key":"ref49","doi-asserted-by":"crossref","first-page":"505","DOI":"10.1016\/S0065-7743(07)42032-2","article-title":"Chapter 32 To Market, To Market\u2013 2006","volume":"42","author":"S Hegde","year":"2007","journal-title":"Annual Reports in Medicinal Chemistry"},{"key":"ref50","doi-asserted-by":"crossref","first-page":"455","DOI":"10.1016\/S0065-7743(08)00025-0","article-title":"To Market, To Market\u20142007","volume":"43","author":"S Hegde","year":"2008","journal-title":"Annual Reports in Medicinal Chemistry"},{"key":"ref51","doi-asserted-by":"crossref","first-page":"577","DOI":"10.1016\/S0065-7743(09)04428-5","article-title":"Chapter 28 To Market, To Market\u20142008","volume":"44","author":"S Hegde","year":"2009","journal-title":"Annual Reports in Medicinal Chemistry"},{"key":"ref52","first-page":"466","article-title":"Annual Reports in Medicinal Chemistry","volume":"45","author":"S Hegde","year":"2010"},{"key":"ref53","doi-asserted-by":"crossref","first-page":"433","DOI":"10.1016\/B978-0-12-386009-5.00002-3","article-title":"To Market, To Market\u20142010","volume":"46","author":"J Bronson","year":"2011","journal-title":"Annual Reports in Medicinal Chemistry"},{"key":"ref54","doi-asserted-by":"crossref","first-page":"499","DOI":"10.1016\/B978-0-12-396492-2.00031-X","article-title":"To Market, To Market\u20142011","volume":"47","author":"J Bronson","year":"2012","journal-title":"Annual Reports in Medicinal Chemistry"},{"key":"ref55","first-page":"471","article-title":"Annual Reports in Medicinal Chemistry","volume":"48","author":"J Bronson","year":"2013"},{"key":"ref56","doi-asserted-by":"crossref","first-page":"437","DOI":"10.1016\/B978-0-12-800167-7.00027-4","article-title":"To Market, To Market\u20142013","volume":"49","author":"J Bronson","year":"2014","journal-title":"Annual Reports in Medicinal Chemistry"},{"key":"ref57","unstructured":"IQVIA [Internet]. Welcome to IQVIA [Cited: 04 Oct 2018]. Available from: https:\/\/www.iqvia.com\/<\/ext-link>."},{"key":"ref58","unstructured":"World Bank [Internet]. World Bank Country and Lending Groups [Cited: 04 Oct 2018]. Available from: https:\/\/datahelpdesk.worldbank.org\/knowledgebase\/articles\/906519-world-bank-country-and-lending-groups<\/ext-link>."},{"key":"ref59","unstructured":"European Commission [Internet]. What is an SME? [Cited: 04 Oct 2018]. Available from: http:\/\/ec.europa.eu\/growth\/smes\/business-friendly-environment\/sme-definition_en<\/ext-link>."},{"issue":"3","key":"ref60","first-page":"10","article-title":"Antibiotic resistance in Africa-discerning the enemy and plotting a defence","volume":"25","author":"IN Okeke","year":"2003","journal-title":"Africa Health"},{"issue":"3","key":"ref61","doi-asserted-by":"crossref","first-page":"e1001974","DOI":"10.1371\/journal.pmed.1001974","article-title":"Antibiotic resistance in India: drivers and opportunities for action","volume":"13","author":"R Laxminarayan","year":"2016","journal-title":"PLoS medicine"},{"issue":"12","key":"ref62","doi-asserted-by":"crossref","first-page":"1840","DOI":"10.3201\/eid1312.070629","article-title":"Hospitalizations and deaths caused by methicillin-resistant Staphylococcus aureus, United States, 1999\u20132005","volume":"13","author":"E Klein","year":"2007","journal-title":"Emerging infectious diseases"},{"issue":"3","key":"ref63","doi-asserted-by":"crossref","first-page":"688","DOI":"10.1111\/jlme.12079","article-title":"Approval and withdrawal of new antibiotics and other antiinfectives in the US, 1980\u20132009","volume":"41","author":"K Outterson","year":"2013","journal-title":"The Journal of Law, Medicine & Ethics"},{"issue":"12","key":"ref64","doi-asserted-by":"crossref","first-page":"e830","DOI":"10.1016\/j.ijid.2012.08.001","article-title":"An oral carbapenem, but only now intravenous penicillin: the paradox of Japanese antimicrobials","volume":"16","author":"BA Rogers","year":"2012","journal-title":"International Journal of Infectious Diseases"},{"key":"ref65","unstructured":"Magdalena Bujar, Neil McAuslane, Lawrence Liberti. New drug approvals in ICH countries 2005\u20132014, R&D Briefing 57: CIRS-Centre for Innovation in Regulatory Science; 2015. Available from: http:\/\/www.cirsci.org\/sites\/default\/files\/CIRS_R&D_57_ICH_%20approval_%20times_2005-2014_%2006072015.pdf<\/ext-link>."}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/dx.plos.org\/10.1371\/journal.pone.0205166","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,5,9]],"date-time":"2020-05-09T09:27:59Z","timestamp":1589016479000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0205166"}},"subtitle":[],"editor":[{"given":"Joel","family":"Lexchin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2018,10,16]]},"references-count":65,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2018,10,16]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0205166","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,10,16]]}}}