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书名:USP dictionary of USAN and international drug names 2014

责任者:U.S. Pharmacopeia.

ISBN\ISSN:9781936424290 1076-4275

出版时间:2014

出版社:United States Pharmacopeia

分类号:医药、卫生

版次:50th ed.


前言

The text of this Dictionary of nonproprietary names, brand names, code designations, and Chemical Abstracts Service registry numbers for drugs has been published continually since 1963 by the United States Pharmacopeial Convention, Inc. (USP), as a public service and particularly to support the United States Adopted Names (USAN) program which began in 1961. It is prepared under the aegis of the USP Nomenclature, Safety and Labeling Expert Committee.
50th Edition
This Dictionary, now in its fiftieth edition, is the annual compilation of United States Adopted Names (for which the abbreviation, USAN, generally is used). It is cumulative from June 15, 1961, when the U.S. Adopted Names program began. It incorporates the text of the publication previously known as USAN and the USP Dictionary of Drug Names and supersedes the 2012 edition and all earlier editions of the dictionary.
Supplements to the Dictionary are published bimonthly in the Nomenclature section of Pharmacopeial Forum (PF), USP's Journal of Standards Development and Official Compendia Revision. Starting in 2011, the PF is available only in the electronic format, and can be accessed through the Internet without a charge. The new names and revisions of existing names in supplements are cumulatively included in the next published edition of the Dictionary.
The Federal Food, Drug, and Cosmetic Act (FDCA) gives the Food and Drug Administration (FDA) the authority to designate official nonproprietary (established) names for drugs and drug ingredients (i.e., drug products, drug substances, and excipients), including those used in USP— NF (FDCA §508). However, FDA has rarely if ever exercised this authority, choosing instead as provided in FDCA §502(e)(1 and 3) to use the drug substance or drug product name recognized in USP-NF, or in the absence of a com-pendial name the "common or usual" name, such as a drug substance name given by USAN. (Names given by FDA in the course of clearing articles for marketing by issuance of an NDA, ANDA, or BLA, have no statutory basis, but have been termed "interim proprietary names" by FDA, pending designation of a statutorily-provided name such as by USP; the courts have upheld this regulatory practice). The practical effect of this statutory nonproprietary naming mechanism is to give deference to names recognized in USP-NF, and also USAN (since the USP Nomenclature committee only very rarely designates a drug substance name that varies from that given by USAN). See discussion of the role of nonproprietary names, below, and FDA regulations, at 21 CFR §299.5(e).
The USAN and the current compendial—United States Pharmacopeia (USP) and National Formulary (NF)— names are printed in boldface type. The International Non-proprietary Names (INN), British Approved Names (BAN) and Japanese Accepted Names (JAN), along with other miscellaneous names, appear in regular lightface type.
Included herein are 160 new U.S. Adopted Names released since publication of the previous edition of this book, as well as additions of other names for drugs. This edition reflects also hundreds of changes affecting information given in previously published entries.
The need for such compilations grows ever greater as the lists lengthen. The body of compounds in active use as drugs does not increase greatly, because new and better drugs tend to displace older drugs intended for the same purposes. On the other hand, new brand names may appear long after a drug is first marketed. The number of nonproprietary names increases steadily because, once assigned, a name remains on record and may not be reassigned even though the compound that it designates has been abandoned. Although rarely done, a brand name may be recycled and applied to another drug. Notable, too, are changes in the ingredients of combination drug products, while retaining the same brand name.
This book lists 11,526 nonproprietary drug name entries. These entries contain more than 3,473 brand names; 6,284 code designations (including 401 NSC numbers); and more than 13,328 CAS registry numbers. There are 9,758 graphics depicted. The total number of USAN herein is 5,312.
All International Nonproprietary Names (INN) published by the World Health Organization from the start of the INN program in 1953 through 2012 are included in this book. Where an INN or other international name (BAN, JAN) exists for a drug that is covered by a boldface entry, the entry designates whether the INN, BAN, or JAN is the same as the corresponding USAN or USP or NF name or differs, in which case the difference is shown.
As is stated in this preface under USAN Procedure, there is increasing emphasis on the worldwide adoption of the same name for each therapeutic substance in view of the manifest advantages it offers to better communication and world trade. Thus the policy of in cluding all INN in this Dictionary lends added perspective and serves to reinforce the aim for more uniformity.
Appendixes, which follow the main alphabetic list, are included on (I) brand names for USAN and other nonpro-prietary names; (II) USAN and USP and NF names listed by categories; (III) molecular formulas; (IV) code designations for USAN and other nonproprietary names; (V) UNII codes for USAN and other nonproprietary names; (VI) CAS registry numbers and NSC numbers; (VII) guiding principles for coining U.S. Adopted Names for drugs; (VIII) guiding principles for coining U.S. Adopted Names for contact lens materials; and (IX) USAN submission forms.
With respect to the legal status of trademarks cited as brand names herein, inquiries should be directed to the U.S. Patent Office.
The database of this Dictionary is maintained on a computer with storage and retrieval capabilities designed to facilitate future revisions and additions to the text as needed. Completeness and accuracy are of course paramount objectives in a compilation such as this. Suggestions of corrections or additions to the text will be welcomed for future consideration.
USP Nomenclature, Safety and Labeling Expert Committee
A USP committee, specifically responsible for nomenclature, was established in 1985 to better standardize USP and NF titles among the standard-writing committees. Later, aspects of labeling have been included in the committee's responsibility.
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts as adopted pursuant to the USP Bylaws, this Dictionary is prepared under the aegis of the USP Nomenclature, Safety and Labeling Expert Committee for 2010-2015, which currently comprises: Loyd V.Allen, Ph.D. Mary B. Baker, Pharm.D., M.B.A. Lawrence H. Block, Ph.D. Dawn M. Boothe, DVM, Ph.D. David H. Campen, M.D. Mrunal S. Chapekar, Ph.D. Stephanie Y. Crawford, Ph.D., M.P.H. Steven J. Dentali, Ph.D. Dennis E. Doherty, M.D. Abraham G. Hartzema, Ph.D., Pharm.D., M.S.P.H. Kent T. Johnson, M.S.Pharm.

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目录

How To Use This Book 7

Preface 9

USP Nomenclature, Safety and Labeling Expert Committee 10

USAN Council 10

USAN Review Board 11

USANProgram 11

USAN Procedure 12

Pronunciation 13

Role of Nonproprietary Names-Federal Law andUSP 13

International Nonproprietary Names 14

International Cooperation 14

Pharmacy Equivalent Names 15

FDA Orphan Drugs 15

Chemical Nomenclature 15

Indentification of Names by Number 16

UNII Description 17

Graphic Formulas 17

Molecular Weights 17

Radioactive Pharmaceuticals 17

BrandNames 17

Code Designations 18

Summary of Types of Information Provided 18

Acknowledgments 18

Pronounciation Guide for Drug Names 21

Pronounciation of Secondary Words 22

Abbreviations 27

Revisions to the 2013 Dictionary 29

Main List

United States Adopted Names (USAN), Compendial (USP and NF) Names, and Other Nonproprietary Names for Drugs 31

Appendices

I — Brand Names for USAN and Other Nonproprietary Names 1223

II — USAN and USP and NF Names Listed by Category 1259

III — Molecular Formulas 1305

IV— Code Designations for USAN and Other Nonproprietary Names 1397

V — UNII Codes for USAN and Other Nonproprietary Names 1449

VI —CAS Registry Numbers 1599

VII — Guiding Principles for Coining United States Adoped Names for Drugs 1703

VIII — Guiding Principles for Coining United States Adopted Names for Contact Lens Materials 1721

IX — USAN Submission Forms 1727

Historical Note 1753

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