DOCSLIB.ORG

Mortality Among Users of Amphetamine-Type Stimulants

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Mortality Among Users of Amphetamine-Type Stimulants Global Burden of Disease Mental Disorders and Illicit Drug Use Expert Group Jessica Singleton, Louisa Degenhardt, Wayne Hall and Tomas Zabransky Mortality among users of amphetamine type stimulants Illicit Drugs Discussion Paper No. 4 GBD2005 Mental Disorders and Illicit Drug Use Expert Group www.gbd.unsw.edu.au MORTALITY AMONG USERS OF AMPHETAMINE TYPE STIMULANTS Jessica Singleton, Louisa Degenhardt, Wayne Hall and Tomas Zabransky Illicit Drugs Discussion Paper No. 4 Recommended citation: Singleton, J., Degenhardt, L., Hall, W., & Zabransky, T. (2008). Mortality among users of amphetamine-type stimulants. Global Burden of Disease Mental Disorders and Illicit Drug Use Expert Group, Illicit drugs discussion paper No. 4. National Drug and Alcohol Research Centre, University of NSW: Sydney. ISBN: 978 0 7334 2691 9 ©NATIONAL DRUG AND ALCOHOL RESEARCH CENTRE, UNIVERSITY OF NEW SOUTH WALES, SYDNEY, 2008 This work is copyright. You may download, display, print and reproduce this material in unaltered form only (retaining this notice) for your personal, non-commercial use or use within your organisation. All other rights are reserved. Requests and enquiries concerning reproduction and rights should be addressed to the information manager, National Drug and Alcohol Research Centre, University of New South Wales, Sydney,NSW 2052, Australia. GBD2005 Mental Disorders and Illicit Drug Use Expert Group www.gbd.unsw.edu.au Table of contents Overview and recommendations ....................................................................................... 1 1. Introduction ............................................................................................................... 2 2. Method ...................................................................................................................... 3 2.1. Identifying studies ......................................................................................... 3 2.2. Included studies ........................................................................................... 3 2.3. Excluded studies ........................................................................................... 4 2.4. Data extraction ............................................................................................. 4 2.5. Quality score ................................................................................................ 4 2.6. Calculation of comparable estimates ............................................................ 4 3. Results ....................................................................................................................... 6 3.1. All-cause mortality ....................................................................................... 7 3.2. Pooled estimates ......................................................................................... 13 4. Discussion and conclusions ..................................................................................... 14 4.1. Limitations .................................................................................................. 15 4.2. Conclusions ................................................................................................ 15 5. References ............................................................................................................... 17 Appendix A: Database information .................................................................................. 18 Appendix B: Search strings for literature searches ............................................................. 19 Appendix C: Number of articles identified from ATS mortality search combinations ........ 21 GBD2005 Mental Disorders and Illicit Drug Use Expert Group www.gbd.unsw.edu.au List of tables Table 2. Cohort studies investigating mortality associated with ATS use ..................... 10 Table 3. Excluded studies investigating mortality associated with ATS use ................. 12 List of figures Figure 1. Flowchart of search strategy to identify articles reporting on mortality associated with amphetamine type stimulant use .......................................................................... 6 GBD2005 Mental Disorders and Illicit Drug Use Expert Group www.gbd.unsw.edu.au Acknowledgements Dr Sharlene Kaye National Drug and Alcohol Research Centre, Sydney Professor Shane Darke National Drug and Alcohol Research Centre, Sydney GBD2005 Mental Disorders and Illicit Drug Use Expert Group www.gbd.unsw.edu.au Overview and recommendations • This discussion paper outlines the results of a comprehensive search of the peer- reviewed literature to identify studies of mortality among people who use amphetamine type stimulants (ATS). • Three electronic databases were searched (EMBASE, Medline and PsychINFO) and “grey” literature was located using online libraries with contributions from trained librarians and experts in drug research. • The peer-reviewed search resulted in 2187 articles and an additional 9 grey literature sources. After thorough review, 72 articles were identified as reporting on the mortality of ATS users. Only 7 of these provided data from cohort studies that could be used to estimate mortality rates. • Overall, both the amount and quality of data on mortality was poor. The geographic spread of the information was also restricted to predominantly high income countries in Western Europe. The limited detail reported in the results was also problematic. Standardised mortality ratios were rarely reported and consequently crude mortality rates had to be used. • Attempts were made to calculate crude mortality rates for six of the cohort studies. A pooled crude mortality rate of 0.72/100 person years was derived. • Only one cohort of ATS users, in the Czech Republic, reported standardised mortality ratios (SMRs): they were 6.22 overall, 5.87 for males and 7.84 for females. • There are insufficient data from cohort studies of dependent users of ATS to evaluate the number of deaths due to specific causes (eg: suicide, overdose). Mortality due to individual causes cannot currently be estimated in a comparative risk assessment for ATS except as captured in separate estimates of injecting drug use (which may or may not be ATS injection). • The risk of non-fatal acute myocardial infarction may be analysed depending upon the results of a separate review. • Given widespread use of ATS globally[1], the known non-fatal adverse effects of use[2] and the elevated mortality rate reported here, cohort studies investigating the morbidity and mortality associated with such drug use should be a research priority. Results of such studies should be reported in a standard and consistent way, with significant improvements in reporting of mortality rates by including person years of follow up, standardised mortality ratios and specific causes of death. 1 GBD2005 Mental Disorders and Illicit Drug Use Expert Group www.gbd.unsw.edu.au 1. Introduction The global prevalence of the use of amphetamine type stimulants (ATS) rapidly increased during the 1990s. In some countries, demand has continued to increase (eg: South Africa and Iraq), while in others there has been a recent decline in use (e.g. Spain, United States of America)[1]. ATS are currently the dominant substance of concern in the Pacific and in several countries in East Asia[3]. There is clearly an imperative to estimate the extent of mortality attributable to ATS use. This is the first comprehensive global review of the mortality associated with dependent ATS use. A variety of definitions of amphetamines and stimulants exist in the literature. “Amphetamines” can include: amphetamine, methamphetamine, 3,4- methylenedioxymethamphetamine (MDMA – commonly referred to as Ecstasy), methcathinone, and ephedrine. They may also include pharmaceutical forms such as phentermine. For the Global Burden of Disease project, use of “amphetamine type stimulants” refers to use of amphetamine and methamphetamine. Where the data are available, the misuse of pharmaceutical amphetamines (used largely to treat attention deficit disorder and as appetite suppressants) will also be included. The current paper is a review of the literature on mortality associated with the dependent use of amphetamine type stimulants. Limitations of the data mean that only all-cause mortality can be discussed. 2 GBD2005 Mental Disorders and Illicit Drug Use Expert Group www.gbd.unsw.edu.au 2. Method 2.1. Identifying studies A systematic literature review was conducted which identified peer reviewed articles and other sources of data describing ATS related mortality. After consultation with qualified librarians, tailored search strings were devised and used to search three electronic databases: EMBASE, Medline and PsycINFO (see Appendix A). This combination of databases provides the most complete coverage of catalogued literature. Search strings contained keywords and database-specific terms (MeSH headings, EMTREE terms and explode terms). Search strings were developed for four themes: amphetamine type stimulants, drug use, mortality epidemiology and cohort studies (see Appendix B). Multiple variations of the four search themes were combined to produce a set of results (see Appendix C). All results were limited to human subjects and publication years between 1990 and 2007. Any cohort studies published between 1980 and 1989 were also included. Grey literature reporting on ATS related mortality was identified using online grey literature databases, library databases and general online searches (the complete
Load more

Recommended publications
  • Title 16. Crimes and Offenses Chapter 13. Controlled Substances Article 1
    TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS § 16-13-1. Drug related objects (a) As used in this Code section, the term: (1) "Controlled substance" shall have the same meaning as defined in Article 2 of this chapter, relating to controlled substances. For the purposes of this Code section, the term "controlled substance" shall include marijuana as defined by paragraph (16) of Code Section 16-13-21. (2) "Dangerous drug" shall have the same meaning as defined in Article 3 of this chapter, relating to dangerous drugs. (3) "Drug related object" means any machine, instrument, tool, equipment, contrivance, or device which an average person would reasonably conclude is intended to be used for one or more of the following purposes: (A) To introduce into the human body any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (B) To enhance the effect on the human body of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; (C) To conceal any quantity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state; or (D) To test the strength, effectiveness, or purity of any dangerous drug or controlled substance under circumstances in violation of the laws of this state. (4) "Knowingly" means having general knowledge that a machine, instrument, tool, item of equipment, contrivance, or device is a drug related object or having reasonable grounds to believe that any such object is or may, to an average person, appear to be a drug related object.
    [Show full text]
  • Meth/Amphetamine Use and Associated HIV: Implications for Global Policy and Public Health
    International Journal of Drug Policy 21 (2010) 347–358 Contents lists available at ScienceDirect International Journal of Drug Policy journal homepage: www.elsevier.com/locate/drugpo Review Meth/amphetamine use and associated HIV: Implications for global policy and public health Louisa Degenhardt ∗,1, Bradley Mathers 2, Mauro Guarinieri 3, Samiran Panda 4, Benjamin Phillips 5, Steffanie A. Strathdee 6, Mark Tyndall 7, Lucas Wiessing 8, Alex Wodak 9, John Howard 10, the Reference Group to the United Nations on HIV and injecting drug use National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW 2052, Australia article info abstract Article history: Amphetamine type stimulants (ATS) have become the focus of increasing attention worldwide. There are Received 29 May 2009 understandable concerns over potential harms including the transmission of HIV. However, there have Received in revised form 30 October 2009 been no previous global reviews of the extent to which these drugs are injected or levels of HIV among Accepted 24 November 2009 users. A comprehensive search of the international peer-reviewed and grey literature was undertaken. Multiple electronic databases were searched and documents and datasets were provided by UN agencies and key experts from around the world in response to requests for information on the epidemiology of use. Keywords: Amphetamine or methamphetamine (meth/amphetamine, M/A) use was documented in 110 countries, Methamphetamine Amphetamine and injection in 60 of those. Use may be more prevalent in East and South East Asia, North America, South HIV Africa, New Zealand, Australia and a number of European countries. In countries where the crystalline Injecting form is available, evidence suggests users are more likely to smoke or inject the drug; in such countries, Epidemiology higher levels of dependence may be occurring.
    [Show full text]
  • Amphetamine-Type Stimulant Use Asia Region in the Southeast Blood-Borne Viruses Andof HIV Other and the Transmission Linkthe Between
    25 The link between paper ANCD research amphetamine-type stimulant use and the transmission of HIV and other blood-borne viruses in the Southeast Asia region 25 The link between paper ANCD research amphetamine-type stimulant use and the transmission of HIV and other blood-borne viruses in the Southeast Asia region Andrea Fischer, Susan Curruthers, Robert Power, Steve Allsop and Louisa Degenhardt Macfarlane Burnet Institute for Medical Research and Public Health in partnership with the National Drug Research Institute, Curtin University A report prepared for the Australian National Council on Drugs, June 2012 © Australian National Council on Drugs 2013 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without the written permission of the publisher. Published by the Australian National Council on Drugs PO Box 205, Civic Square ACT 2608 Telephone: 02 6166 9600 Fax: 02 6162 2611 Email: [email protected] Website: www.ancd.org.au National Library of Australia Cataloguing-in-Publication data The link between amphetamine-type stimulant use and the transmission of HIV and other blood-borne viruses in the Southeast Asia region / Andrea Fischer … [et al.] ISBN: 9788770182799 ANCD research paper; 25. Includes bibliographic references. HIV (Viruses) — Southeast Asia — Transmission. HIV infections — Epidemiology — Southeast Asia. Intravenous drug abusers — Diseases — Southeast Asia. Intravenous drug abuse — Southeast Asia. Fischer, Andrea. Macfarlane Burnet Institute for Medical Research and Public Health (Melbourne, Vic.) National Drug Research Institute (Australia). Australian National Council on Drugs. 614.5993095 Editor: Julie Stokes Design: Starkis Design Acknowledgement: This work has been supported by funding from the Australian Government Department of Health and Ageing.
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2015/0119330 A1 Mcgee Et Al
    US 2015O1 19330A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2015/0119330 A1 McGee et al. (43) Pub. Date: Apr. 30, 2015 (54) SUBSTRATES AND INHIBITORS OF PROLYL Publication Classification OLGOPEPTIDASE AND FIBROBLAST ACTIVATION PROTEIN AND METHODS OF (51) Int. Cl. USE C07K 7/06 (2006.01) (71) Applicant: The Board of Regents of the University C07K5/II (2006.01) of Oklahoma, Norman, OK (US) C07K5/09 (2006.01) (52) U.S. Cl. (72) Inventors: Patrick A. McGee, Oklahoma City, OK CPC ................. C07K 7/06 (2013.01); C07K5/0817 (US); Kenneth W. Jackson, Edmond, OK (US); Victoria J. Christiansen, (2013.01); C07K5/1019 (2013.01) Oklahoma City, OK (US) (21) Appl. No.: 14/398,886 (57) ABSTRACT (22) PCT Filed: May 3, 2013 Inhibitors of fibroblast activation protein alpha (FAP) and (86). PCT No.: PCT/US2013/0395.43 Prolyl Oligopeptidase (POP) are disclosed, along with their S371 (c)(1), use in various therapies related to conditions, diseases, and (2) Date: Nov. 4, 2014 disorders involving abnormal cell proliferation Such as malig nancies and angiogenesis, and in neural disorders such as Related U.S. Application Data Alzheimer's disease. Stalk portions of the inhibitor mol (60) Provisional application No. 61/643,001, filed on May ecules, and substrates of FAP and POP, are also disclosed and 4, 2012, provisional application No. 61/793,183, filed may be used, for example, in screening methods for identify on Mar. 15, 2013. ing Such inhibitors. US 201S/O119330 A1 Iaun3]+. ;0zzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzz… Patent Application Publication Apr. 30, 2015 Sheet 2 of 11 US 201S/O119330 A1 §§§§§§§§§§§ §§§§§§§§§§§§)§§§§§3 §§§§§§§§§§¶¡¿$¢$$$$$$§§§§§ $$$ §28, $$¢£€$£§§§§§§§§ §§§§§§§§§§§§§§§§§§ ? §§?ae, § § §§§§§§§§§§§§§§§§§§§§§??$$§§§§§§§§§§§§ $ §§§§§§§§§§§§§§§ a.
    [Show full text]
  • Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DIX to the HTSUS—Continued
    20558 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DEPARMENT OF THE TREASURY Services, U.S. Customs Service, 1301 TABLE 1.ÐPHARMACEUTICAL APPEN- Constitution Avenue NW, Washington, DIX TO THE HTSUSÐContinued Customs Service D.C. 20229 at (202) 927±1060. CAS No. Pharmaceutical [T.D. 95±33] Dated: April 14, 1995. 52±78±8 ..................... NORETHANDROLONE. A. W. Tennant, 52±86±8 ..................... HALOPERIDOL. Pharmaceutical Tables 1 and 3 of the Director, Office of Laboratories and Scientific 52±88±0 ..................... ATROPINE METHONITRATE. HTSUS 52±90±4 ..................... CYSTEINE. Services. 53±03±2 ..................... PREDNISONE. 53±06±5 ..................... CORTISONE. AGENCY: Customs Service, Department TABLE 1.ÐPHARMACEUTICAL 53±10±1 ..................... HYDROXYDIONE SODIUM SUCCI- of the Treasury. NATE. APPENDIX TO THE HTSUS 53±16±7 ..................... ESTRONE. ACTION: Listing of the products found in 53±18±9 ..................... BIETASERPINE. Table 1 and Table 3 of the CAS No. Pharmaceutical 53±19±0 ..................... MITOTANE. 53±31±6 ..................... MEDIBAZINE. Pharmaceutical Appendix to the N/A ............................. ACTAGARDIN. 53±33±8 ..................... PARAMETHASONE. Harmonized Tariff Schedule of the N/A ............................. ARDACIN. 53±34±9 ..................... FLUPREDNISOLONE. N/A ............................. BICIROMAB. 53±39±4 ..................... OXANDROLONE. United States of America in Chemical N/A ............................. CELUCLORAL. 53±43±0
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 8,158,152 B2 Palepu (45) Date of Patent: Apr
    US008158152B2 (12) United States Patent (10) Patent No.: US 8,158,152 B2 Palepu (45) Date of Patent: Apr. 17, 2012 (54) LYOPHILIZATION PROCESS AND 6,884,422 B1 4/2005 Liu et al. PRODUCTS OBTANED THEREBY 6,900, 184 B2 5/2005 Cohen et al. 2002fOO 10357 A1 1/2002 Stogniew etal. 2002/009 1270 A1 7, 2002 Wu et al. (75) Inventor: Nageswara R. Palepu. Mill Creek, WA 2002/0143038 A1 10/2002 Bandyopadhyay et al. (US) 2002fO155097 A1 10, 2002 Te 2003, OO68416 A1 4/2003 Burgess et al. 2003/0077321 A1 4/2003 Kiel et al. (73) Assignee: SciDose LLC, Amherst, MA (US) 2003, OO82236 A1 5/2003 Mathiowitz et al. 2003/0096378 A1 5/2003 Qiu et al. (*) Notice: Subject to any disclaimer, the term of this 2003/OO96797 A1 5/2003 Stogniew et al. patent is extended or adjusted under 35 2003.01.1331.6 A1 6/2003 Kaisheva et al. U.S.C. 154(b) by 1560 days. 2003. O191157 A1 10, 2003 Doen 2003/0202978 A1 10, 2003 Maa et al. 2003/0211042 A1 11/2003 Evans (21) Appl. No.: 11/282,507 2003/0229027 A1 12/2003 Eissens et al. 2004.0005351 A1 1/2004 Kwon (22) Filed: Nov. 18, 2005 2004/0042971 A1 3/2004 Truong-Le et al. 2004/0042972 A1 3/2004 Truong-Le et al. (65) Prior Publication Data 2004.0043042 A1 3/2004 Johnson et al. 2004/OO57927 A1 3/2004 Warne et al. US 2007/O116729 A1 May 24, 2007 2004, OO63792 A1 4/2004 Khera et al.
    [Show full text]
  • Introduction
    DEVELOPMENT OF A NOVEL 99mTc-LABELLED BRAIN PERFUSION AGENT H.G. ABBAS, XA9847991 Atomic Energy Medical Centre, Mayo Hospital M. JAVED, A. SAEEDA Institute of Nuclear Medicine and Oncology M.S. IQBAL Himont Laboratories M.S. KHAN Atomic Energy Medical Centre, Mayo Hospital Lahore, Pakistan Abstract A method has been described for radiolabeling of salbutamol with technetium-99m (99mTc). To a 1 ml solution, containing 5 mg salbutamol and 2 mg of ascorbic acid, was added a clear solution (10 |o.l) of SnCl2.2H2O (100 u.g) in distilled water. The pH of the solution was adjusted to 8.5, mixed gently with 10 mCi (370 MBq) of 99mTc elute and incubated at room temperature for 15 minutes. The resulting solution was passed through 0.22 (i filter and radiolabeled fraction was quantified using paper chromatography. The radiochemical analysis, employing the use of above- mentioned radioanalytical technique, revealed that greater than 97% of the radioactivity was bound 99m to salbutamol and rest of the activity was in the form of free pertechnitate ( Tc04). Biological data, obtained after i.v. injection of 99mTc-salbutamol to female albino rabbits, revealed a fair uptake in the brain at 30 min and 60 min post injection time intervals. On the basis of animal biodistribution data it is suggested that 99mTc-salbutamol can be successfully applied as a brain perfusion agent. Introduction The clinical value of measuring regional cerebral blood flow (rCBF) has long been recognized [1]. Nuclear medicine is rapidly establishing itself as an important tool in the invivo study of the brain neurochemistry.
    [Show full text]
  • The Injection of Amphetamine Type Stimulants and Associations With
    The global epidemiology of methamphetamine injection: A review of the evidence on use and associations with HIV and other harm Louisa Degenhardt, Bradley Mathers, Mauro Guarinieri, Samiran Panda, Benjamin Phillips, Steffanie Strathdee, Mark Tyndall, Lucas Wiessing, Alex Wodak on behalf of the Reference Group to the United Nations on HIV and injecting drug use National Drug and Alcohol Research Centre UNIVERSITY OF NEW SOUTH WALES Sydney, Australia ISBN 978 0 7334 2589 9 © NDARC 2007 This work is copyright. You may download, display, print and reproduce this material in unaltered form only (retaining this notice) for your personal, non-commercial use or use within your organisation. All other rights are reserved. Requests and enquiries concerning reproduction and rights should be addressed to the Information Manager, National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW 2052, Australia. ii Acknowledgements This report is a product of, and was reviewed by, the Reference Group to the United Nations on HIV and injecting drug use. The Reference Group includes: • Tasnim Azim • Mauro Guarinieri • Matthew Hickman • Adeeba Kamarulzaman • Kasia Malinowska-Sempruch • Fabio Mesquita • Azarakhsh Mokri • Olanrewaju Olusola Onigbogi • Fred Owiti • Samiran Panda • Steffanie A Strathdee • Fayzal Sulliman • Abdalla Toufik • Jallal Toufiq • Mark Tyndall • Lucas Wiessing (See http://www.idurefgroup.unsw.edu.au//idurgweb.nsf/page/Reference%20Group) This report was also reviewed by the Secretariat to the Reference Group: The
    [Show full text]
  • Muuttuneet Radiofarmaseuttiset INN-Nimet/1.1.2018
    Muuttuneet radiofarmaseuttiset INN-nimet/1.1.2018 Englanti Latina Suomi cesium(131Cs)kloridi cesium (131Cs) chloride cesii (131Cs) chloridum cesium[131Cs ]-kloridi klormerodriini(197Hg) chlormerodrin (197Hg) chlormerodrinum (197Hg) klormerodriini[197Hg ] syanokobalamiini(57Co) cyanocobalamin (57Co) cyanocobalaminum (57Co) syanokobalamiini[57Co ] syanokobalamiini(58Co) cyanocobalamin (58Co) cyanocobalaminum (58Co) syanokobalamiini[58Co ] syanokobalamiini(60Co) cyanocobalamin (60Co) cyanocobalaminum (60Co) syanokobalamiini[60Co ] etjodaatti(131I)öljy ethiodized oil (131I) oleum ethiodatum (131I) etjodaatti[131I ]-öljy ferri(59Fe)sitraatti-injektioneste ferric (59Fe) citrate injection ferri (59Fe) citratis injectio ferri[59Fe ]-sitraatti-injektioneste fibrinogeeni(125I) fibrinogen (125I) fibrinogenum (125I) fibrinogeeni[125I ] florbenatsiini(18F) florbenazine (18F) florbenazinum (18F) florbenatsiini[18F ] florbetabeeni(18F) florbetaben (18F) florbetabenum (18F) florbetabeeni[18F ] florbetapiiri(18F) florbetapir (18F) florbetapirum (18F) florbetapiiri[18F ] florilglutamiinihappo(18F) florilglutamic acid (18F) acidum florilglutamicum (18F) florilglutamiinihappo[18F ] flortanidatsoli(18F) flortanidazole (18F) flortanidazolum (18F) flortanidatsoli[18F ] flortausipiiri(18F) flortaucipir (18F) flortaucipirum (18F) flortausipiiri[18F] flotegatidi(18F) flotegatide (18F) flotegatidum (18F) flotegatidi[18F ] flusiklatidi(18F) fluciclatide (18F) fluciclatidum (18F) flusiklatidi[18F ] flusikloviini(18F) fluciclovine (18F) fluciclovinum (18F) flusikloviini[18F
    [Show full text]
  • Supplement 12 December 1988
    m CUMULATIVE SUPPLEMENT i 2 JAH~ 88·DEC~ 88 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 8TH EDITION U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF MANAGEMENT SUBSCRIBE NOW! Available in March 1989 New 9th Edition APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 9 TH EDITION i989 CONTENTS • Prescription Drug Product List • OTe Drug Product List • List of Drug Products Approved Under Section 505 of the Act by the Division of Blood and Blood Products • Discontinued Drug Product List • Orphan Drug Products with Exclusive Approval • Drug Products Which Must Demonstrate in vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution • Biopharmaceutic Guidance Availability • ANDA Suitability Petitions • Patent and Exclusivity Information See Subscription Form Inside Back Cover APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 8TH EDITION CUMULATIVE SUPPLEMENT 12 DECEMBER 1988 CONTENTS PAGE 1.0 INTRODUCTION iii 1.1 How to Use the Cumulative Supplement iii 1.2 Products Requiring Revised Labeling for Full Approval v 1.3 Applicant (Name) Changes v -1-o4·---l:f"ra-z-odofle~·Hyd-roetr"'o-rtde· "... " ..... ... -"-~~-~.-..y.i-..-~_ 1.5 Report of Counts for the Prescription Orug Product List vii 2.0 DRUG PRODUCT LISTS 2.1 Prescription Drug Product List 1 2.2 OTC Drug Product List 64 2.3 _U,t ~ nrug Products in the Division of B1ooe! and Blood Products Approved Under Section 505 of the Act).,. d.--t:;" 66 2.4 Orphan Oru~ Products with Exclusive Approval (:'7 2.5 Drug Products Which Must Demonstrate in vivo 9ioavai1ability Only if Product Fails to Achieve Ac1equate nissolution 72 2.6 Biopharmaceutic Guidance Availability 73 2.7 ANnA Suitability Petitions 7~ PATENT AND EXCLlJS I V lTV I NFOR~1.1\ TI ON AonE~ourl A.
    [Show full text]
  • Harmonized Tariff Schedule of the United States (2004) -- Supplement 1 Annotated for Statistical Reporting Purposes
    Harmonized Tariff Schedule of the United States (2004) -- Supplement 1 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2004) -- Supplement 1 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABACAVIR 136470-78-5 ACEXAMIC ACID 57-08-9 ABAFUNGIN 129639-79-8 ACICLOVIR 59277-89-3 ABAMECTIN 65195-55-3 ACIFRAN 72420-38-3 ABANOQUIL 90402-40-7 ACIPIMOX 51037-30-0 ABARELIX 183552-38-7 ACITAZANOLAST 114607-46-4 ABCIXIMAB 143653-53-6 ACITEMATE 101197-99-3 ABECARNIL 111841-85-1 ACITRETIN 55079-83-9 ABIRATERONE 154229-19-3 ACIVICIN 42228-92-2 ABITESARTAN 137882-98-5 ACLANTATE 39633-62-0 ABLUKAST 96566-25-5 ACLARUBICIN 57576-44-0 ABUNIDAZOLE 91017-58-2 ACLATONIUM NAPADISILATE 55077-30-0 ACADESINE 2627-69-2 ACODAZOLE 79152-85-5 ACAMPROSATE 77337-76-9 ACONIAZIDE 13410-86-1 ACAPRAZINE 55485-20-6 ACOXATRINE 748-44-7 ACARBOSE 56180-94-0 ACREOZAST 123548-56-1 ACEBROCHOL 514-50-1 ACRIDOREX 47487-22-9 ACEBURIC ACID 26976-72-7
    [Show full text]
  • Marrakesh Agreement Establishing the World Trade Organization
    No. 31874 Multilateral Marrakesh Agreement establishing the World Trade Organ ization (with final act, annexes and protocol). Concluded at Marrakesh on 15 April 1994 Authentic texts: English, French and Spanish. Registered by the Director-General of the World Trade Organization, acting on behalf of the Parties, on 1 June 1995. Multilat ral Accord de Marrakech instituant l©Organisation mondiale du commerce (avec acte final, annexes et protocole). Conclu Marrakech le 15 avril 1994 Textes authentiques : anglais, français et espagnol. Enregistré par le Directeur général de l'Organisation mondiale du com merce, agissant au nom des Parties, le 1er juin 1995. Vol. 1867, 1-31874 4_________United Nations — Treaty Series • Nations Unies — Recueil des Traités 1995 Table of contents Table des matières Indice [Volume 1867] FINAL ACT EMBODYING THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS ACTE FINAL REPRENANT LES RESULTATS DES NEGOCIATIONS COMMERCIALES MULTILATERALES DU CYCLE D©URUGUAY ACTA FINAL EN QUE SE INCORPOR N LOS RESULTADOS DE LA RONDA URUGUAY DE NEGOCIACIONES COMERCIALES MULTILATERALES SIGNATURES - SIGNATURES - FIRMAS MINISTERIAL DECISIONS, DECLARATIONS AND UNDERSTANDING DECISIONS, DECLARATIONS ET MEMORANDUM D©ACCORD MINISTERIELS DECISIONES, DECLARACIONES Y ENTEND MIENTO MINISTERIALES MARRAKESH AGREEMENT ESTABLISHING THE WORLD TRADE ORGANIZATION ACCORD DE MARRAKECH INSTITUANT L©ORGANISATION MONDIALE DU COMMERCE ACUERDO DE MARRAKECH POR EL QUE SE ESTABLECE LA ORGANIZACI N MUND1AL DEL COMERCIO ANNEX 1 ANNEXE 1 ANEXO 1 ANNEX
    [Show full text]