APPROVED
`DRUG
`PRODUCTS
`
`WITH
`
`THERAPEUTIC
`EQUIVALENCE
`EVALUATIONS
`34th 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 MEDICAL PRODUCTS AND TOBACCO
`OFFICE OF GENERIC DRUGS
`
`2014
`
`FAMY CARE - EXHIBIT 1024-0001
`
`

`

`APPROVED DRUG PRODUCTS
`with
`THERAPEUTIC EQUIVALENCE EVALUATIONS
`
`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 2013
`
`34th EDITION
`
`U.S DEPARTMENT OF HEALTH AND HUMAN SERVICES
`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`OFFICE OF MEDICAL PRODUCTS AND TOBACCO
`OFFICE OF GENERIC DRUGS
`
`2014
`
`FAMY CARE - EXHIBIT 1024-0002
`
`

`

`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`APPROVED DRUG PRODUCTS
`with
`Therapeutic Equivalence Evaluations
`
`CONTENTS
`
`PREFACE TO THIRTY FOURTH EDITION
`
`INTRODUCTION
`Content and Exclusion
`Therapeutic Equivalence-Related Terms
`Statistical Criteria for Bioequivalence
`Reference Listed Drug
`General Policies and Legal Status
`Practitioner/User Responsibilities
`Therapeutic Equivalence Evaluations Codes
`Description of Special Situations
`Therapeutic Equivalence Code Change for
`Drug Entity
`Change of the Therapeutic Equivalence Evaluation for Single Product
`Discontinued Section
`Changes to the Orange Book
`Availability of the Edition
`
`HOW TO USE THE DRUG PRODUCTS LISTS
`Key Sections for Using the Drug Product Lists
`Drug Product Illustration
`Therapeutic Equivalence Evaluations Illustration
`
`1.1
`
`1.2
`
`1.3
`
`1.4
`
`1.5
`
`1.6
`
`1.7
`
`1.8
`
`1.9
`
`1.10
`
`1.11
`
`1.12
`
`1.13
`
`2.1
`
`2.2
`
`2.3
`
`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 Biologics 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
`Product Name Index
`Product Name Index Listed by Applicant
`Uniform Terms
`
`PATENT AND EXCLUSIVITY INFORMATION ADDENDUM
`Patent and Exclusivity Lists
`Patent and Exclusivity Terms
`
`PAGE
`
`iv
`
`vi
`
`vi
`
`vi
`
`viii
`
`xi
`
`xi
`
`xiii
`
`xx
`
`xxii
`
`xxiii
`
`xxiii
`
`xxiii
`
`xxiv
`
`2-1
`
`2-1
`
`2-3
`
`2-4
`
`3-1
`
`4-1
`
`5-1
`
`6-1
`
`7-1
`
`8-1
`
`A-i
`
`B-i
`
`C-i
`
`AD1
`ADA1
`ADB1
`
`FAMY CARE - EXHIBIT 1024-0003
`
`

`

`FOOD AND DRUG ADMINISTRATION
`CENTER FOR DRUG EVALUATION AND RESEARCH
`APPROVED DRUG PRODUCTS
`with
`Therapeutic Equivalence Evaluations
`
`PREFACE TO THIRTY FOURTH EDITION
`
`The publication Approved Drug Products with Therapeutic Equivalence
`the List commonly known as the Orange Book identifies drug
`Evaluations
`on the basis of safety and effectiveness
`by the Food and
`approved
`products
`Drug Administration FDA under
`the
`the Federal Food Drug and Cosmetic Act
`Act
`Drugs on the market approved only on the basis of safety covered by
`Donnatal
`the ongoing Drug Efficacy Study Implementation
`review
`and Librax Capsules or pre1938 drugs
`Tablets
`Phenobarbital
`Tablets
`included in this publication
`are not
`The main criterion for the
`inclusion of any product
`is that
`is the subject of an application
`the product
`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
`drug
`In addition the List contains
`equivalence evaluations
`product
`therapeutic
`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
`in the area
`to promote public education
`of drug product selection and to foster containment of health care costs
`equivalence evaluations in this publication are not official
`Therapeutic
`the Act
`actions affecting the legal status of products under
`
`FDA
`
`the Publication
`To contain drug costs virtually every
`Background of
`laws and/or
`the substitution of
`regulations that encourage
`state has adopted
`drug products
`These state laws generally require either
`that substitution be
`the positive formulary approach
`limited to drugs on
`specific list
`or that
`those prohibited by
`particular list
`be permitted for all drugs except
`it
`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
`that
`FDA could not serve the needs of each
`became apparent
`state on an individual basis
`The Agency also recognized that providing
`single list
`based on common criteria would be preferable to evaluating drug
`on the basis of differing definitions and criteria in various state
`products
`on May 31 1978 the Commissioner of
`laws
`result
`As
`the Food and Drug
`Administration sent
`letter
`to officials of each state stating FDATs
`intent
`list of all prescription drug products
`that are approved
`by FDA
`to provide
`for safety and effectiveness
`along with therapeutic
`equivalence
`determinations
`for multisource prescription products
`
`in January 1979
`included only
`The List was distributed as
`proposal
`It
`currently marketed prescription drug products
`by FDA through new drug
`approved
`NDA5
`ANDA5 under
`and abbreviated new drug applications
`the
`applications
`the Act
`provisions of Section 505 of
`
`FDATs
`in the List reflect
`The therapeutic equivalence evaluations
`application of specific criteria to the multisource prescription drug products
`the Act
`under Section 505 of
`These evaluations are
`on the List approved
`presented in the form of code
`letters that
`indicate the basis for the
`evaluation made
`in the Introduction
`An explanation of
`the code appears
`
`and basis of FDAT5
`the background
`complete discussion of
`therapeutic
`equivalence evaluation policy was published in the Federal Register on
`January 12 1979 44 FR 2932
`The final rule which includes FDATs
`responses
`on the proposal was published in the Federal Register
`to the public comments
`
`iv
`
`FAMY CARE - EXHIBIT 1024-0004
`
`

`

`on October 31 1980 45 FR 72582
`The first publication October 1980 of
`incorporated appropriate corrections
`and
`the final version of
`the List
`additions
`Each subsequent edition has
`included the new approvals
`and made
`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
`drug products with monthly supplements
`list of approved
`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 505b
`the Act
`for those drugs may not be submitted for
`of
`time and if allowed to be submitted would be tentatively
`specified period of
`approved
`information concerning the listed drugs which
`and provides patent
`also may delay the approval of ANDAs or Section 505b
`The
`applications
`Addendum also provides additional
`information that may be helpful
`to those
`new drug application to the Agency
`submitting
`
`The Agency intends to use this publication to further
`its objective of
`obtaining input and comment
`on the publication itself
`and related Agency
`on how the publication can be
`you have
`procedures
`Therefore
`comments
`if
`improved please send them to the Director Division of Labeling and Program
`Support HFD610 Office of Generic Drugs Center
`for Drug and Evaluation and
`7620 Standish Place Rockville MD 20855
`Research
`Comments
`received are
`publicly available to the extent allowable under
`the Freedom of
`Information
`regulations
`
`FAMY CARE - EXHIBIT 1024-0005
`
`

`

`INTRODUCTION
`
`1.1 Content and Exclusion
`
`four parts
`The List
`approved prescription drug
`is composed of
`equivalence evaluations
`products with therapeutic
`approved
`OTC drug products
`overthecounter
`for those drugs that may not be marketed
`without NDAs or ANDAs because they are not covered
`under existing OTC
`drug products with approval under Section 505 of
`the Act
`monographs
`for Biologics Evaluation and Research
`administered by the Center
`and
`cumulative
`list of approved
`that have never been marketed are for
`products
`exportation are for military use have
`been discontinued from marketing or
`had their approvals withdrawn for other
`have
`than safety or efficacy reasons
`to being discontinued from marketing
`This publication also
`subsequent
`includes indices of prescription and OTC drug products
`by trade or established
`if
`name holder of
`no trade name exists and by applicant
`the approved
`name
`All established names for active ingredients generally conform
`application
`compendial names or United States Adopted Names USAN as
`to official
`prescribed in 21 CFR 299.4e
`The latter list
`includes applicants
`names
`as abbreviated in this publication in addition
`list of uniform terms is
`provided
`
`drug patent and exclusivity information for the
`An Addendum contains
`Prescription OTC Discontinued Drug Product Lists and for the Drug Products
`with Approval under Section 505 of
`for
`the Act Administered by the Center
`Biologics Evaluation and Research
`The publication may include additional
`the Agency deems appropriate to disseminate
`information that
`
`Prior to the 6th Edition the publication had excluded OTC drug products
`505 of
`and drug products with approval under Section
`the Act administered by
`for Biologics Evaluation and Research
`the Center
`because the main purpose of
`to provide information to states regarding FDAs
`the publication was
`recommendation
`as to which generic prescription drug products were acceptable
`for drug product selection
`The 1984 Amendments required the
`candidates
`Agency to begin publishing an up-to-date list of all marketed drug products
`been approved
`for safety and efficacy
`OTC as well as prescription that have
`are required
`and for which new drug applications
`
`the 1984 Amendments
`are given tentative
`Under
`some drug products
`approvals
`include drug products with tentative approval
`The Agency will not
`in the List Tentative approval
`lists are available at ANDA Generic Drug
`Approvals
`becomes
`When
`the tentative approval
`full approval
`through
`subsequent action letter
`to the application holder
`the Agency will
`list
`and the final approval date in the appropriate approved
`drug product
`drug
`list
`product
`
`the
`
`identified
`on the List are not
`Distributors or repackagers of products
`Because distributors or repackagers are not
`required to notify FDA when they
`to another
`from one approved manufacturer
`shift
`their sources of supply
`it
`not possible to maintain complete information linking product approval with
`the distributor or repackager handling the products
`
`is
`
`1.2 Therapeutic Equivalence-Related Terms
`
`Pharmaceutical Equivalents
`are considered pharmaceutical
`Drug products
`they contain the same active ingredients are of
`the same
`equivalents if
`
`dLf
`
`pt
`
`ap Va
`
`FAMY CARE - EXHIBIT 1024-0006
`
`

`

`2014
`34TH EDITION
`LIST
`APPROVED DRUG PRODUCT
`PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
`
`See report
`
`footnote for information regarding report content
`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
`FAMY CARE - EXHIBIT 1024-0007
`
`