FDA橙皮书2013年--第33版

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FDA橙皮书2013年--第33版.pdf
FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH APPROVED DRUG PRODUCTS with Therapeutic Equivalence Evaluations
CONTENTS
PAGE
PREFACE TO THIRTY THIRD EDITION………………………………………
..…................
iv
1 INTRODUCTION
...................................................................................................................
vi
1.1
Content and Exclusion
......................................................................................................
vi
1.2
Therapeutic Equivalence-Related Terms
.........................................................................
vi
1.3
Statistical Criteria for Bioequivalence
.............................................................................
viii
1.4
Reference Listed Drug
.......................................................................................................
x
1.5
General Policies and Legal Status
...................................................................................
xi
1.6
Practitioner/User Responsibilities
.....................................................................................
xi
1.7
Therapeutic Equivalence Evaluations Codes
.................................................................
xiii
1.8 Description of Special Situations.....................................................................................xx
1.9 Therapeutic Equivalence Code Change for a Drug Entity.............................................xxii
1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product.................... xxiii
1.11 Discontinued Section.................................................................................................... xxiii
1.12 Changes to the Orange Book....................................................................................... xxiii
1.13 Availability of the Edition............................................................................................... xxiv
2
HOW TO USE THE DRUG PRODUCTS LISTS
..............................................................
2-1
2.1
Key Sections for Using the Drug Product Lists …………………….….………………
......
2-1
2.2
Drug Product Illustration ……………………………………………
..….…………….……..
2-3
2.3
Therapeutic Equivalence Evaluations Illustration ………………….….…………..………2-4 DRUG PRODUCT LISTS
Prescription Drug Product List ……………………………………….…………….………………
...
3-1
OTC Drug Product List ……………………………………………….…………….…………………4-1
Drug Products with Approval under Section 505 of the Act Administered
Drug Products Which Must Demonstrate in vivo Bioavailability
by the Center for Biologics Evaluation and Research List
...……….…….………………...
5-1
Discontinued Drug Product List .…………………………………………….…….………………
....
6-1
Orphan Products Designations and Approvals List …………….………….…….………………
..
7-1
Only if Product Fails to Achieve Adequate Dissolution …………………
..………………………..
8-1
APPENDICES
A.
Product Name Index ……….…
...………………………….………..……………………A-1
B.
Product Name Index Listed by Applicant ………………….……
..……………………..
B-1
C.
Uniform Terms …………………………………………….………
..…………...………...
C-1
PATENT AND EXCLUSIVITY INFORMATION ADDENDUM ……….……..………………..........AD1
A.
Patent and Exclusivity Lists …………………………….…
..……..……………..……ADA1
B.
Patent and Exclusivity Terms
...……………………….….………...…………………ADB1

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jjb2005

橙皮书（OrangeBook）为FDA 为适应《Hatch-Waxman 法案》而设立的新药专利链接制度。法案规定品牌药企业必须将其品牌药物的专利信息提交FDA，FDA 对其汇总编辑，每月增订，年终出版成册。
橙皮书明确列出了新药所涉及的所有专利以及市场专营保护信息。

Lynn0904cy

这个是有在线的吧？

syhorchid

谢谢分享

coriolan

谢谢，虽然不一定用到，至少可以提高英语

jianglinluye

谢谢分享

小金库

非常感谢分享