{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T22:58:17Z","timestamp":1790117897680,"version":"4.0.1"},"reference-count":27,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2011,5,14]],"date-time":"2011-05-14T00:00:00Z","timestamp":1305331200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2011,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data were obtained from the FDA, Micromedex, Medline, and Lexis\u2010Nexis. Descriptive analyses were used to classify product discontinuations by therapeutic category, time frame for discontinuation, and reason for withdrawal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>There were 740 NMEs approved by the FDA during the study period. As of 1 December 2010, the number of drugs discontinued was 118 (15.9%). Discontinuations were the highest for antiparasitic products, insecticides, and repellents (6, 33.3% of approvals), systemic hormonal preparations excluding sex hormones and insulins (5, 33.3%), musculo\u2010skeletal system (11, 32.4%), diagnostic agents (16, 28.1%), and anti\u2010infectives for systemic use (27, 25.2%). Safety was the primary reason for withdrawing 26 drugs (3.5% of approvals).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Approximately one in seven approved NMEs were discontinued from the market in the period of 1980\u20132009. Less than one\u2010quarter (22%) of the total withdrawals were attributed to safety reasons. An ongoing evaluation of new drugs throughout their product life cycle is important to determine their efficacy, safety, and value to society. Copyright \u00a9 2011 John Wiley &amp; Sons, Ltd.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.2155","type":"journal-article","created":{"date-parts":[[2011,5,14]],"date-time":"2011-05-14T03:20:03Z","timestamp":1305343203000},"page":"772-777","source":"Crossref","is-referenced-by-count":143,"title":["Market withdrawal of new molecular entities approved in the United States from 1980 to 2009"],"prefix":"10.1002","volume":"20","author":[{"given":"Zaina P.","family":"Qureshi","sequence":"first","affiliation":[{"name":"South Carolina Center of Economic Excellence for Medication Safety and Efficacy and the Southern Network on Adverse Reactions (SONAR), South Carolina College of Pharmacy University of South Carolina  Columbia SC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrique","family":"Seoane\u2010Vazquez","sequence":"additional","affiliation":[{"name":"International Center for Pharmaceutical Economics and Policy Massachusetts College of Pharmacy and Health Sciences  Boston Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosa","family":"Rodriguez\u2010Monguio","sequence":"additional","affiliation":[{"name":"School of Public Health and Health Sciences University of Massachusetts  Amherst Massachusetts USA"},{"name":"The Institute for Global Health University of Massachusetts  Amherst Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kurt B.","family":"Stevenson","sequence":"additional","affiliation":[{"name":"College of Medicine Ohio State University  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheryl L.","family":"Szeinbach","sequence":"additional","affiliation":[{"name":"College of Pharmacy Ohio State University  Columbus Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,5,14]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"Federal Food Drug and Cosmetic Act. (FFDCA)Sec. 505. New Drugs; and Sec. 601.2. Applications for Biologics Licenses."},{"key":"e_1_2_8_3_1","unstructured":"Center for Drug Evaluation and Research. Office of New Drugs.Drug Shortage Management.2006Manual of Policies and Procedures. MAPP 6003.1 Effective Date: 11\/13\/95; 9\/26\/2006. Available at:http:\/\/www.fda.gov\/downloads\/AboutFDA\/ReportsManualsForms\/StaffPoliciesandProcedures\/UCM079936.pdf[ Accessed 20 February 2010.]"},{"key":"e_1_2_8_4_1","unstructured":"Federal Food Drug and Cosmetic Act. (FFDCA). Sec. 506C. Discontinuance of a Lifesaving Product."},{"key":"e_1_2_8_5_1","unstructured":"Federal Food Drug and Cosmetic Act. (FFDCA). Sec. 314.80. Post\u2010marketing Reporting of Adverse Drug Experiences; and Sec. 600.80. Post\u2010marketing Reporting of Adverse Experiences [biologics]."},{"key":"e_1_2_8_6_1","unstructured":"Federal Food Drug and Cosmetic Act. (FFDCA). Sec. 601.5. Revocation of License."},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.281.18.1753"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.165.12.1363"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.287.17.2215"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhealeco.2007.10.007"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.socscimed.2005.01.004"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200629020-00008"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1D110"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.281.18.1728"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpubeco.2007.09.010"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.2307\/3666313"},{"key":"e_1_2_8_17_1","unstructured":"Federal Food Drug and Cosmetic Act. (FFDCA). Sec. 505. New Drugs."},{"key":"e_1_2_8_18_1","unstructured":"Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology.Levaquin\u00ae(levofloxacin) oral solution 250\u2009mg\/10\u2009ml BPCA Drug Use Review. FDA July 10 2008.http:\/\/www.fda.gov\/ohrms\/dockets\/ac\/08\/briefing\/2008\u20104399b1\u201012%20%28Levaquin%20%28levofloxacin%29%20Use%20Review%29.pdf[Accessed 20 February 2010]"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.1998.00651.x"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.2174\/157488607781668855"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.045021"},{"key":"e_1_2_8_22_1","first-page":"186","article-title":"Why physicians start or stop prescribing a drug: literature review and formulary implications","volume":"37","author":"Groves KEM","year":"2002","journal-title":"Formulary"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/sys.20106"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2004.6.761"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200528010-00001"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1248"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s002280100265"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd1774"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.2155","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.2155","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.2155","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,23]],"date-time":"2023-09-23T08:16:49Z","timestamp":1695457009000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.2155"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,5,14]]},"references-count":27,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2011,7]]}},"alternative-id":["10.1002\/pds.2155"],"URL":"https:\/\/doi.org\/10.1002\/pds.2155","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,5,14]]}}}