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`WITH
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`THERAPEUTIC
`EQUIVALENCE
`EVALUATIONS
`
`27th EDITION
`
`THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER
`SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
`
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`OFFICE OF PHARMACEUTICAL SCIENCE
`OFFICE OF GENERIC DRUGS
`
`2007
`
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`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`OFFICE OF PHARMACEUTICAL SCIENCE
`OFFICE OF GENERIC DRUGS
`
`2007
`
`
`
`The products in this list have been approved under section 505 of the
`Federal Food, Drug, and Cosmetic Act. This volume is current through
`December 31, 2006.
`
`27th EDITION
`
`S6 *v '
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`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`APPROVED DRUG PRODUCTS
`with
`Therapeutic Equivalence Evaluations
`
`
`
`CONTENTS
`
`PREFACE TO TWENTY SEVENTH EDITION
`
`PAGE
`
`iv
`
`v
`v
`v
`vii
`ix
`ix
`x
`xii
`xix
`xxi
`xxi
`xxii
`xxii
`xxii
`
`.2-1
`2-1
`2-3
`2-4
`
`3-1
`4-1
`
`5-1
`6-1
`7-1
`
`8-1
`
`A-1
`B-1
`C-1
`
`AD1
`ADA1
`.ADB1
`
`INTRODUCTION
`1
`Content and Exclusion
`1.1
`Therapeutic Equivalence-Related Terms
`1.2
`Statistical Criteria for Bioequivalence
`1.3
`Reference Listed Drug
`1.4
`General Policies and Legal Status
`1.5
`Practitioner/User Responsibilities
`1.6
`Therapeutic Equivalence Evaluations Codes
`1.7
`Description of Special Situations
`1.8
`Therapeutic Equivalence Code Change for a Drug Entity
`1.9
`1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product
`1.11 Discontinued Section
`1.12 Changes to the Orange Book
`1.13 Availability of the Edition
`
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`ÕÕÕÈ
`
`2 HOW TO USE THE DRUG PRODUCTS LISTS ...
`2.1
`Key Sections for Using the Drug Product Lists ..
`2.2
`Drug Product Illustration
`2.3
`Therapeutic Equivalence Evaluations Illustration
`
`DRUG PRODUCT LISTS
`Prescription Drug Product List
`OTC Drug Product List
`Drug Products with Approval under Section 505 of the Act Administered
`by the Center for Biologies Evaluation and Research List
`Discontinued Drug Product List
`Orphan Products Designations and Approvals List
`Drug Products Which Must Demonstrate in vivo Bioavailability
`Only if Product Fails to Achieve Adequate Dissolution
`
`APPENDICES
`A. Product Name Index
`B. Product Name Index Listed by Applicant
`C. Uniform Terms
`
`PATENT AND EXCLUSIVITY INFORMATION ADDENDUM
`A. Patent and Exclusivity Lists
`B. Patent and Exclusivity Terms
`
`iii
`
`

`

`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`APPROVED DRUG PRODUCTS
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`Therapeutic Equivalence Evaluations
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`ÕÕÕÈ
`
`PREFACE TO TWENTY SEVENTH EDITION
`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
`Act). Drugs on the market approved only on the basis of safety (covered by
`the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal®
`Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital
`Tablets]) are not included in this publication. The main criterion for the
`inclusion of any product is that the product is the subject of an application
`with an effective approval that has not been withdrawn for safety or efficacy
`reasons. Inclusion of products on the List is independent of any current
`regulatory action through administrative or judicial means against a drug
`product. In addition, the List 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 Act.
`Background of the Publication. To contain drug costs, virtually every
`state has adopted laws and/or regulations that encourage the substitution of
`drug products. These state laws generally require either that substitution be
`limited to drugs on a specific list (the positive formulary approach) or that
`it be permitted for all drugs except those prohibited by a particular list
`(the negative formulary approach). Because of the number of requests in the
`late 1970s for FDA assistance in preparing both positive and negative
`formularies, it became apparent that FDA could not serve the needs of each
`state on an individual basis. The Agency also recognized that providing a
`single list based on common criteria would be preferable to evaluating drug
`products on the basis of differing definitions and criteria in various state
`laws. As a result, on May 31, 1978, the Commissioner of the Food and Drug
`Administration sent a letter to officials of each state stating FDA's intent
`to provide a list of all prescription drug products that are approved by FDA
`for safety and effectiveness, along with therapeutic equivalence
`determinations for multisource prescription products.
`The List was distributed as a proposal in January 197 9.
`It included only
`currently marketed prescription drug products approved by FDA through new drug
`applications (NDAs) and abbreviated new drug applications (ANDAs) under the
`provisions of Section 505 of the Act.
`The therapeutic equivalence evaluations in the List reflect FDA's
`application of specific criteria to the multisource prescription drug products
`on the List approved under Section 505 of the Act.
`These evaluations are
`presented in the form of code letters that indicate the basis for the
`evaluation made. An explanation of the code appears in the Introduction.
`A complete discussion of the background and basis of FDA's therapeutic
`equivalence evaluation policy was published in the Federal Register on
`January 12, 1979 (44 FR 2932). The final rule, which includes FDA's responses
`to the public comments on the proposal, was published in the Federal Register
`on October 31, 1980 (45 FR 72582). The first publication, October 1980, of
`iii
`
`

`

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`the final version of the List incorporated appropriate corrections and
`Each subsequent edition has included the new approvals and made
`additions.
`appropriate changes in data.
`On September 24, 1984, the President signed into law the Drug Price
`Competition and Patent Term Restoration Act (1984 Amendments). The 1984
`Amendments require that FDA, among other things, make publicly available a
`list of approved drug products with monthly supplements. The Approved Drug
`Products with Therapeutic Equivalence Evaluations publication and its monthly
`Cumulative Supplements satisfy this requirement. The Addendum to this
`publication identifies drugs that qualify under the 1984 Amendments for
`periods of exclusivity (during which ANDAs or applications described in
`Section 505(b)(2) of the Act for those drugs may not be submitted for a
`specified period of time and, if allowed to be submitted, would be tentatively
`approved) and provides patent information concerning the listed drugs which
`also may delay the approval of ANDAs or Section 505(b) (2) applications. The
`Addendum also provides additional information that may be helpful to those
`submitting a new drug application to the Agency.
`The Agency intends to use this publication to further its objective of
`obtaining input and comment on the publication itself and related Agency
`procedures. Therefore, if you have comments on how the publication can be
`improved, please send them to the Director, Division of Labeling and Program
`Support, HFD-610, Office of Generic Drugs, Center for Drug and Evaluation and
`Research, 7500 Standish Place, Rockville, MD 20855. Comments received are
`publicly available to the extent allowable under the Freedom of Information
`regulations.
`
`ÕÖÈ
`
`iv
`
`

`

`1. INTRODUCTION
`
`1.1 Content and Exclusion
`The List is composed of four parts: (1) approved prescription drug
`products with therapeutic equivalence evaluations; (2) approved
`over-the-counter (OTC) drug products for those drugs that may not be marketed
`without NDAs or ANDAs because they are not covered under existing OTC
`monographs; (3) drug products with approval under Section 505 of the Act
`administered by the Center for Biologies Evaluation and Research; and (4) a
`cumulative list of approved products that have never been marketed, are for
`exportation, are for military use, have been discontinued from marketing, or
`have had their approvals withdrawn for other than safety or efficacy reasons
`subsequent to being discontinued from marketing.1 This publication also
`includes indices of prescription and OTC drug products by trade or established
`name (if no trade name exists) and by applicant name (holder of the approved
`application). All established names for active ingredients generally conform
`to official compendial names or United States Adopted Names (USAN) as
`prescribed in (21 CFR 299.4(e)). The latter list includes applicants' names
`as abbreviated in this publication; in addition, a list of uniform terms is
`provided. An Addendum contains drug patent and exclusivity information for
`the Prescription and OTC Drug Product Lists, and for the Drug Products with
`Approval under Section 505 of the Act Administered by the Center for Biologies
`Evaluation and Research. The publication may include additional information
`that the Agency deems appropriate to disseminate.
`Prior to the 6th Edition, the publication had excluded OTC drug products
`and drug products with approval under Section 505 of the Act administered by
`the Center for Biologies Evaluation and Research because the main purpose of
`the publication was to provide information to states regarding FDA's
`recommendation as to which generic prescription drug products were acceptable
`candidates for drug product selection. The 1984 Amendments required the
`Agency to begin publishing an up-to-date list of all marketed drug products,
`OTC as well as prescription, that have been approved for safety and efficacy
`and for which new drug applications are required.
`Under the 1984 Amendments, some drug products were given tentative
`approvals. Prior to the effective date, the Agency will not include drug
`products with tentative approval in the List; however, they are available at
`http://www.fda.gov/cder/ogd/approvals/default.htm. When the tentative
`approval becomes a full approval through a subsequent action letter to the
`application holder, the Agency will list the drug product and the final,
`effective approval date in the appropriate approved drug product list.
`Distributors or repackagers of products on the List are not identified.
`Because distributors or repackagers are not required to notify FDA when they
`shift their sources of supply from one approved manufacturer to another, it is
`not possible to maintain complete information linking product approval with
`the distributor or repackager handling the products.
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`ÖÈ
`
`1.2 Therapeutic Equivalence-Related Terms
`Drug products are considered pharmaceutical
`Pharmaceutical Equivalents.
`equivalents if they contain the same active ingredient(s) , are of the same
`dosage form, route of administration and are identical in strength or
`concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules).
`Pharmaceutically equivalent drug products are formulated to contain the same
`amount of active ingredient in the same dosage form and to meet the same or
`
`1 Newly approved products are added to parts 1, 2, or 3, of the List, depending on the dispensing
`requirements (prescription or OTC) or approval authority, unless the Orange Book staff is
`otherwise notified before publication.
`
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`
`Drug products are considered to be therapeutic
`Therapeutic Equivalents.
`equivalents only if they are pharmaceutical equivalents and if they can be
`expected to have the same clinical effect and safety profile when administered
`to patients under the conditions specified in the labeling.
`FDA classifies as therapeutically equivalent those products that meet the
`following general criteria: (1) they are approved as safe and effective; (2)
`they are pharmaceutical equivalents in that they (a) contain identical amounts
`of the same active drug ingredient in the same dosage form and route of
`administration, and (b) meet compendial or other applicable standards of
`strength, quality, purity, and identity; (3) they are bioequivalent in that
`(a) they do not present a known or potential bioequivalence problem, and they
`meet an acceptable in vitro standard, or (b) if they do present such a known
`or potential problem, they are shown to meet an appropriate bioequivalence
`standard; (4) they are adequately labeled; (5) they are manufactured in
`compliance with Current Good Manufacturing Practice regulations. The concept
`of therapeutic equivalence, as used to develop the List, applies only to drug
`products containing the same active ingredient(s) and does not encompass a
`comparison of different therapeutic agents used for the same condition (e.g.,
`propoxyphene hydrochloride vs. pentazocine hydrochloride for the treatment of
`pain). Any drug product in the List repackaged and/or distributed by other
`than the application holder is considered to be therapeutically equivalent to
`the application holder's drug product even if the application holder's drug
`product is single source or coded as non-equivalent (e.g., BN). Also,
`distributors or repackagers of an application holder's drug product are
`considered to have the same code as the application holder. Therapeutic
`equivalence determinations are not made for unapproved, off-label indications.
`FDA considers drug products to be therapeutically equivalent if they meet
`the criteria outlined above, even though they may differ in certain other
`characteristics such as shape, scoring configuration, release mechanisms,
`packaging, excipients (including colors, flavors, preservatives), expiration
`date/time and minor aspects of labeling (e.g., the presence of specific
`pharmacokinetic information) and storage conditions. When such differences
`are important in the care of a particular patient, it may be appropriate for
`the prescribing physician to require that a particular brand be dispensed as a
`medical necessity. With this limitation, however, FDA believes that products
`classified as therapeutically equivalent can be substituted with the full
`expectation that the substituted product will produce the same clinical effect
`and safety profile as the prescribed product.
`Bioavailab