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Approved Drug Products With Therapeutic Equivalence Evaluations, 37th Edition, 2017

Title:
Approved Drug Products With Therapeutic Equivalence Evaluations, 37th Edition, 2017
Format:
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GPO Stock Number:
917-051-00000-3
Description

The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the list, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The main criterion for the inclusion of any product is that the product is the subject of an application with an approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products in the Orange Book is independent of any current regulatory action through administrative or judicial means against a drug product.

In addition, the Orange Book contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the FD&C Act.

Table of Contents

Table of Contents:

 

PREFACE TO THIRTY SEVENTH EDITION…….……………………………..…................iv

 

1 INTRODUCTION................................................................................................................ vi

 

1.1 Content and Exclusion ................................................................................................... vi

 

1.2 Therapeutic Equivalence-Related Terms ....................................................................... vi

 

1.3 Further Guidance on Bioequivalence ............................................................................. ix

 

1.4 Reference Listed Drug and Reference Standard............................................................ ix

 

1.5 General Policies and Legal Status .................................................................................. x

 

1.6 Practitioner/User Responsibilities ................................................................................... x

 

1.7 Therapeutic Equivalence Evaluations Codes .................................................................xii

 

1.8 Description of Certain Special Situations ...................................................................... xx

 

1.9 Therapeutic Equivalence Code Change for a Drug Entity ........................................... xxiii

 

1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product .................... xxiii

 

1.11 Discontinued Section ..................................................................................................xxiv

 

1.12 Changes to the Orange Book......................................................................................xxiv

 

1.13 Availability of the Edition ..............................................................................................xxv

 

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 FD&C 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

Audience

This publication would appeal to drug manufacturers and manufacturers of equivalent but lower cost drugs, distributors and repackagers of products within the publication, policymakers, the FDA, Congress, and researchers and drug production oversight groups.

Reviews

FDA Law Blog: The Official Blog of Hyman, Phelps, & McNamara, P.C.  Article: Bigger, Better, Faster, Stronger: The New Orange Book Makes Its Debut  by Kurt R. Karst  January 24, 2017

"'On January 25, 2017, The Orange Book data will be updated to reflect the recent publication of the draft guidance for industry "Referencing Approved Drug Products in ANDA Submissions.' [I], and presumably Orange Book aficionados everywhere, are pretty excited about the updates that are coming to [...] the Orange Book."

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2017/01/bigger-bette...

Product Details

Availability Details:
In Stock
USA Price:
$287.00
International Price:
$401.80
Publisher:
Health and Human Services Department, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Medical Products and Tobacco, Office of Generic Drugs
Notes:
O/N 17-004.
Key Phrases:
  • Subscriptions
  • APD17
  • Drugs
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Cover:
Paper
Unit of Issue (US):
1
Unit of Issue (Non-US):
1
Item available Date:
01/11/2017
Last Status Update:
10/18/2017
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