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Volumn 28, Issue 10, 2011, Pages 842-856

Unapproved drugs in the united states and the food and drug administration

Author keywords

drug approval; FDA; unapproved drugs

Indexed keywords

ALPHA TOCOPHEROL; ALPHAPRODINE; AMITRIPTYLINE; BUPHENINE; CARBINOXAMINE; CHLORDIAZEPOXIDE; CHLOROTHIAZIDE; CHLORPROMAZINE; COLCHICINE; CYTOCHROME P450 3A4; DARBAZINE; DEXTROPROPOXYPHENE; EQUAGESIC; GENERIC DRUG; GLYCERYL TRINITRATE; GUAIFENESIN; HEPARIN; HYDROCORTISONE ACETATE; ILLICIT DRUG; ISONIAZID; ISOPROPAMIDE IODIDE PLUS PROCHLORPERAZINE MALEATE; ISOSORBIDE DINITRATE; LEVOTHYROXINE; MARAX; METHOTREXATE; METHYLPREDNISOLONE ACETATE PLUS NEOMYCIN; NEO MEDROL; PLACEBO; RAUTRAX; THALIDOMIDE; UNCLASSIFIED DRUG; UNINDEXED DRUG; WARFARIN;

EID: 82355185799     PISSN: 0741238X     EISSN: 18658652     Source Type: Journal    
DOI: 10.1007/s12325-011-0059-4     Document Type: Review
Times cited : (34)

References (32)
  • 1
    • 84873087400 scopus 로고    scopus 로고
    • US Department of Health and Human Services. Food and Drug Administration Center for Drug Evaluation and Research (CDER) June Accessed March 26, 2011
    • US Department of Health and Human Services. Food and Drug Administration Center for Drug Evaluation and Research (CDER). Marketed Unapproved Drugs - Compliance Policy Guide. June 2006. Available at: http://www.fda.gov/ICECI/ ComplianceManuals/CompliancePolicyGuidanceManual/UCM074382. Accessed March 26, 2011.
    • (2006) Marketed Unapproved Drugs - Compliance Policy Guide
  • 2
    • 82355180309 scopus 로고
    • Wiley and the Pure Food Laws
    • C.D. Fisher 1909 Wiley and the Pure Food Laws Progress 8 91 94
    • (1909) Progress , vol.8 , pp. 91-94
    • Fisher, C.D.1
  • 3
    • 0021930767 scopus 로고
    • Industry invites regulation: The passage of the Pure Food and Drug Act of 1906
    • I.D. Barkan 1985 Industry invites regulation: the passage of the Pure Food and Drug Act of 1906 Am J Public Health 75 18 26 3881052 10.2105/AJPH.75.1.18 1:STN:280:DyaL2M%2FpsVKqsA%3D%3D (Pubitemid 15194819)
    • (1985) American Journal of Public Health , vol.75 , Issue.1 , pp. 18-26
    • Barkan, I.D.1
  • 4
    • 0004263376 scopus 로고    scopus 로고
    • Upton Sinclair. Encyclopedia Britannica. Encyclopedia Britannica Online Accessed March 26, 2011
    • Upton Sinclair. Encyclopedia Britannica. Encyclopedia Britannica Online. Encyclopedia Britannica, 2011. Available at: http://www.britannica.com/ EBchecked/topic/545642/Upton-Sinclair. Accessed March 26, 2011.
    • (2011) Encyclopedia Britannica
  • 5
    • 21744451344 scopus 로고    scopus 로고
    • FDA policy on unapproved drug products: Past, present, and future
    • DOI 10.1345/aph.1E569
    • R. Chhabrar M.E. Kremzner B.J. Kiliany 2005 FDA policy on unapproved drug products: past, present, and future Ann Pharmacother 39 1260 1264 10.1345/aph.1E569 (Pubitemid 40943179)
    • (2005) Annals of Pharmacotherapy , vol.39 , Issue.7-8 , pp. 1260-1264
    • Chhabra, R.1    Kremzner, M.E.2    Kiliany, B.J.3
  • 6
    • 0013056956 scopus 로고
    • Taste of raspberries, taste of death: The 1937 Elixir Sulfanilamide Incident
    • June Accessed March 26, 2011
    • Ballentine C. Taste of raspberries, taste of death: the 1937 Elixir Sulfanilamide Incident. FDA Consumer Magazine, June 1981. Available at: http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/ SulfanilamideDisaster/default.htm. Accessed March 26, 2011.
    • (1981) FDA Consumer Magazine
    • Ballentine, C.1
  • 9
    • 0035288543 scopus 로고    scopus 로고
    • Frances Oldham Kelsey: FDA Medical Reviewer leaves her mark on history
    • Mar-Apr Accessed March 26, 2011
    • Bren L. Frances Oldham Kelsey: FDA Medical Reviewer leaves her mark on history. FDA Consumer Magazine, Mar-Apr 2001. Available at: http://permanent. access.gpo.gov/lps1609/www.fda.gov/fdac/features/2001/201-kelsey.html. Accessed March 26, 2011.
    • (2001) FDA Consumer Magazine
    • Bren, L.1
  • 10
    • 0036869636 scopus 로고    scopus 로고
    • The history of thalidomide
    • DOI 10.1358/dnp.2002.15.9.840066
    • J. Botting 2002 The history of thalidomide Drug News Perspect 15 604 611 12677202 10.1358/dnp.2002.15.9.840066 1:CAS:528:DC%2BD3sXlt1aktg%3D%3D (Pubitemid 36025547)
    • (2002) Drug News and Perspectives , vol.15 , Issue.9 , pp. 604-611
    • Botting, J.1
  • 11
    • 0036338754 scopus 로고    scopus 로고
    • The schizophrenic career of a "monster drug"
    • DOI 10.1542/peds.110.2.404
    • W.A. Silverman 2002 The schizophrenic career of a "monster drug" Pediatrics 110 404 406 12165600 10.1542/peds.110.2.404 (Pubitemid 34833032)
    • (2002) Pediatrics , vol.110 , Issue.2 , pp. 404-406
    • Silverman, W.A.1
  • 12
    • 84873085351 scopus 로고    scopus 로고
    • January 9 Accessed March 26, 2011
    • Autor DM. The Unapproved Universe. January 9, 2007. Available at: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm118338.pdf. Accessed March 26, 2011.
    • (2007) The Unapproved Universe
    • Autor, D.M.1
  • 14
    • 84873088812 scopus 로고    scopus 로고
    • Accessed March 27, 2011
    • Approved Drug Decision Tree. Available at: http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ SelectedEnforcementActionsonUnapprovedDrugs/ucm119916.pdf. Accessed March 27, 2011.
    • Approved Drug Decision Tree
  • 15
    • 84892538239 scopus 로고    scopus 로고
    • Food and Drug Administration. Timed-release drug products containing guaifenesin; Enforcement action
    • US Department of HealthHuman Services.
    • US Department of HealthHuman Services. 2007 Food and Drug Administration. Timed-release drug products containing guaifenesin; enforcement action Federal Register 72 29517 29519
    • (2007) Federal Register , vol.72 , pp. 29517-29519
  • 16
    • 82355179665 scopus 로고    scopus 로고
    • Food and Drug Administration. Carbinoxamine products; Enforcement action dates
    • US Department of HealthHuman Services.
    • US Department of HealthHuman Services. 2006 Food and Drug Administration. Carbinoxamine products; enforcement action dates Federal Register 71 33462 33462
    • (2006) Federal Register , vol.71 , pp. 33462-33462
  • 17
    • 84873082646 scopus 로고    scopus 로고
    • US Department of Health and Human Services Food and Drug Administration March 16 Accessed March 27, 2011
    • US Department of Health and Human Services Food and Drug Administration. Press release: FDA orders 2 companies to stop marketing unapproved nitroglycerin tablets. March 16, 2010. Available at: http://www.fda.gov/newsevents/newsroom/ pressannouncements/ucm204744.htm. Accessed March 27, 2011.
    • (2010) Press Release: FDA Orders 2 Companies to Stop Marketing Unapproved Nitroglycerin Tablets
  • 18
    • 84873084887 scopus 로고    scopus 로고
    • US Department of Health and Human Services. Food and Drug Administration March 16 Accessed March 27, 2011
    • US Department of Health and Human Services. Food and Drug Administration. Questions and answers for consumers about FDA's action involving unapproved nitroglycerin sublingual tablets. March 16, 2010. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ ucm204351.htm. Accessed March 27, 2011.
    • (2010) Questions and Answers for Consumers about FDA's Action Involving Unapproved Nitroglycerin Sublingual Tablets
  • 19
    • 82355192664 scopus 로고    scopus 로고
    • Food and Drug Administration. Drug products containing colchicine for injection; Enforcement action
    • US Department of HealthHuman Services.
    • US Department of HealthHuman Services. 2008 Food and Drug Administration. Drug products containing colchicine for injection; enforcement action Federal Register 75 7565 7567
    • (2008) Federal Register , vol.75 , pp. 7565-7567
  • 20
    • 0034090172 scopus 로고    scopus 로고
    • Colchicine use in cyclosporine treated transplant recipients: How little is too much?
    • P.A. Simkin G.C. Gardner 2000 Colchicine use in cyclosporine treated transplant recipients: how little is too much? J Rheumatol 27 1334 1337 10852250 1:STN:280:DC%2BD3cvotlCqsQ%3D%3D (Pubitemid 30354024)
    • (2000) Journal of Rheumatology , vol.27 , Issue.6 , pp. 1334-1337
    • Simkin, P.A.1    Gardner, G.C.2
  • 21
    • 0026603791 scopus 로고
    • Effect of cyclosporine on colchicine secretion by a liver canalicular transporter studied in vivo
    • 1568732 10.1002/hep.1840150524 1:CAS:528:DyaK38XisVOrtbk%3D
    • K.V. Speeg A.L. Maldonado J. Liaci D. Muirhead 1992 Effect of cyclosporine on colchicine secretion by a liver canalicular transporter studied in vivo Hepatology 15 899 903 1568732 10.1002/hep.1840150524 1:CAS:528:DyaK38XisVOrtbk%3D
    • (1992) Hepatology , vol.15 , pp. 899-903
    • Speeg, K.V.1    Maldonado, A.L.2    Liaci, J.3    Muirhead, D.4
  • 22
    • 0026636982 scopus 로고
    • Effect of cyclosporine on colchicine secretion by a kidney multidrug transporter studied in vivo
    • 1348538 1:CAS:528:DyaK38Xit1Orur4%3D
    • K.V. Speeg A.L. Maldonado J. Liaci D. Muirhead 1992 Effect of cyclosporine on colchicine secretion by a kidney multidrug transporter studied in vivo J Pharmacol Exp Ther 261 50 55 1348538 1:CAS:528:DyaK38Xit1Orur4%3D
    • (1992) J Pharmacol Exp Ther , vol.261 , pp. 50-55
    • Speeg, K.V.1    Maldonado, A.L.2    Liaci, J.3    Muirhead, D.4
  • 23
    • 78649505211 scopus 로고    scopus 로고
    • Colchicine in clinical medicine. A guide for internists
    • 10.1016/j.ejim.2010.09.010
    • G. Cocco D.C.C. Chu S. Pandolfi 2010 Colchicine in clinical medicine. A guide for internists Eur J Intern Med 21 502 508 10.1016/j.ejim.2010.09.010
    • (2010) Eur J Intern Med , vol.21 , pp. 502-508
    • Cocco, G.1    Chu, D.C.C.2    Pandolfi, S.3
  • 24
    • 77955447377 scopus 로고    scopus 로고
    • Oral colchicine (Colcrys) in the treatment and prophylaxis of gout
    • 20687623 10.2165/11205470-000000000-00000 1:CAS:528:DC%2BC3cXhtF2ks7jM
    • L.P.H. Yang 2010 Oral colchicine (Colcrys) in the treatment and prophylaxis of gout Drugs 70 1603 1613 20687623 10.2165/11205470-000000000-00000 1:CAS:528:DC%2BC3cXhtF2ks7jM
    • (2010) Drugs , vol.70 , pp. 1603-1613
    • Yang, L.P.H.1
  • 25
    • 33845579871 scopus 로고    scopus 로고
    • Colchicine today
    • DOI 10.1016/j.jbspin.2006.03.006, PII S1297319X06001837
    • E. Niel J.M. Scherrmann 2006 Colchicine today Joint Bone Spine 73 672 678 17067838 10.1016/j.jbspin.2006.03.006 1:CAS:528:DC%2BD2sXhsFahu70%3D (Pubitemid 44932240)
    • (2006) Joint Bone Spine , vol.73 , Issue.6 , pp. 672-678
    • Niel, E.1    Scherrmann, J.-M.2
  • 26
    • 77954220989 scopus 로고    scopus 로고
    • Colchicine poisoning: The dark side of an ancient drug
    • 10.3109/15563650.2010.495348
    • Y. Finkelstein S.E. Aks J.R. Hutson, et al. 2010 Colchicine poisoning: the dark side of an ancient drug Clin Toxicol (Phila) 48 1422 1431 10.3109/15563650.2010.495348
    • (2010) Clin Toxicol (Phila) , vol.48 , pp. 1422-1431
    • Finkelstein, Y.1    Aks, S.E.2    Hutson, J.R.3
  • 28
    • 82355179664 scopus 로고    scopus 로고
    • Food and Drug Administration. Single-ingredient oral colchicine products; Enforcement action dates
    • US Department of HealthHuman Services.
    • US Department of HealthHuman Services. 2010 Food and Drug Administration. Single-ingredient oral colchicine products; enforcement action dates Federal Register 73 60768 60771
    • (2010) Federal Register , vol.73 , pp. 60768-60771
  • 29
    • 84873099385 scopus 로고    scopus 로고
    • September 6 Accessed March 28, 2011
    • Colcrys® Full Prescribing Information. September 6, 2010. Available at: http://www.colcrys.com/assets/pdf/COLCRYS-Full-Prescribing-Information.pdf. Accessed March 28, 2011.
    • (2010) Colcrys® Full Prescribing Information
  • 30
    • 77953158446 scopus 로고    scopus 로고
    • Incentives for drug development. The curious case of colchicine
    • 20393164 10.1056/NEJMp1003126 1:CAS:528:DC%2BC3cXntVajt7Y%3D
    • A.D. Kesselheim D.H. Solomon 2010 Incentives for drug development. The curious case of colchicine N Engl J Med 362 2045 2047 20393164 10.1056/NEJMp1003126 1:CAS:528:DC%2BC3cXntVajt7Y%3D
    • (2010) N Engl J Med , vol.362 , pp. 2045-2047
    • Kesselheim, A.D.1    Solomon, D.H.2
  • 31
    • 77950525312 scopus 로고    scopus 로고
    • High versus low dosing of oral colchicine for early acute gout flare: Twenty-fourhour outcome of the first multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison colchicine study
    • 20131255 10.1002/art.27327 1:CAS:528:DC%2BC3cXhtFGnu7rE
    • R.A. Terkeltaub D.E. Furst K. Bennett K.A. Kook R.S. Crockett M.W. Davis 2010 High versus low dosing of oral colchicine for early acute gout flare: twenty-fourhour outcome of the first multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-comparison colchicine study Arthritis Rheum 62 1060 1068 20131255 10.1002/art.27327 1:CAS:528:DC%2BC3cXhtFGnu7rE
    • (2010) Arthritis Rheum , vol.62 , pp. 1060-1068
    • Terkeltaub, R.A.1    Furst, D.E.2    Bennett, K.3    Kook, K.A.4    Crockett, R.S.5    Davis, M.W.6
  • 32
    • 33846811717 scopus 로고    scopus 로고
    • Colchicine overdose: The devil in the detail
    • V. Jayaprakash G. Ansell D. Galler 2007 Colchicine overdose: the devil in the detail NZ Med J 120 U2402
    • (2007) NZ Med J , vol.120 , pp. 2402
    • Jayaprakash, V.1    Ansell, G.2    Galler, D.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.