SlideShare a Scribd company logo
1 of 10
THE INTRODUCTION OF AN ORANGE BOOK
DEFINITIONS
 It is the publication of “Approved Drug Products
with Therapeutic Equivalence Evaluations” by
the Food and Drug Administration.
 It is prepared by The Orange Book Staff,
Center for Drug Evaluation and Research.
 It identified drug products on the basis of
safety and effectiveness by the Food and Drug
Administration under the Federal Food, Drug,
and Cosmetics Act.
 Drugs marketed only on the basis of safety or
pre-1938 drugs.
CONTD..
 The list is independent of any current regulatory
action against a drug product.
 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not been withdrawn for safety or efficacy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.
 The FDA does not recommend substituting
drugs that have not been determined to be
bioequivalent.
 Drugs that are not listed as bioequivalent
should not be substituted for each other.
HISTORY
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
January, 1979 The list was distributed (included only currently
marketed prescription drug products approved by FDA through
NDAs and ANDAs under the provisions of section 505 of the Act)
October 31, 1980 The final rule (includes FDA’s response to the
public comments on the proposal) was published in the Federal
Register (45 FR 72582). The list incorporated appropriate
corrections and additions.
OBJECTIVES
To allow
review of
patterns of
access and
usage
To allow
discovery of
use of
unusual
privileges
To allow discovery
of repeated
attempts to bypass
protections
To serve as a
deterrent by its
existence
To supply an
additional
form of user
assurance
CONTENTS OF ORANGE BOOK
1. INTRODUCTION
1.1 Content and Exclusion
1.2 Therapeutic Equivalence-Related Terms
1.3 Statistical Criteria for Bioequivalence
1.4 Reference Listed Drug
1.5 General Policies and Legal Status
1.6 Practitioner/User Responsibilities
1.7 Therapeutic Equivalence Evaluations Codes
1.8 Description of Special Situations
1.9 Therapeutic Equivalence Code Change for a Drug Entity
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
CONTENTS
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
CONTENTS
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 A-1
• B. Product Name Index Listed by
• C. Uniform Terms
PATENT AND EXCLUSIVITY INFORMATION
ADDENDUM
A. Patent and Exclusivity Lists
B. Patent and Exclusivity Terms
The introduction of an orange book

More Related Content

What's hot

Common Technical Document
Common Technical DocumentCommon Technical Document
Common Technical DocumentDr Sukanta sen
 
2. unit II, chapter-2 regulatory authorities and agencies.
2. unit II, chapter-2 regulatory authorities and agencies.2. unit II, chapter-2 regulatory authorities and agencies.
2. unit II, chapter-2 regulatory authorities and agencies.Audumbar Mali
 
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...Audumbar Mali
 
Hatch waxman act & amendments ppt
Hatch waxman act & amendments  pptHatch waxman act & amendments  ppt
Hatch waxman act & amendments pptAlexa Jacob
 
DMF Drug Master File
DMF   Drug Master FileDMF   Drug Master File
DMF Drug Master FileRushi Mendhe
 
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.Audumbar Mali
 
THERAPEUTIC GOODS ADMINISTRATION (TGA) and MHRA
THERAPEUTIC GOODS ADMINISTRATION (TGA) and MHRATHERAPEUTIC GOODS ADMINISTRATION (TGA) and MHRA
THERAPEUTIC GOODS ADMINISTRATION (TGA) and MHRAManikant Prasad Shah
 
PMS (post marketing surveillance)
PMS (post marketing surveillance)PMS (post marketing surveillance)
PMS (post marketing surveillance)SANDEEP LOHMOR
 
New drug application
New drug applicationNew drug application
New drug applicationVKEkbote
 
Pharmaceutical Licecnsing authorites of india
Pharmaceutical Licecnsing authorites of indiaPharmaceutical Licecnsing authorites of india
Pharmaceutical Licecnsing authorites of indiaAtul Bhombe
 
4. Unit-IV:- Clinical Trials.
4. Unit-IV:- Clinical Trials.4. Unit-IV:- Clinical Trials.
4. Unit-IV:- Clinical Trials.Audumbar Mali
 
Generic drugs product development
Generic drugs product developmentGeneric drugs product development
Generic drugs product developmentSachin G
 
5. Unit-V- Regulatory Concepts.
5. Unit-V- Regulatory Concepts.5. Unit-V- Regulatory Concepts.
5. Unit-V- Regulatory Concepts.Audumbar Mali
 

What's hot (20)

Cdsco ppt
Cdsco pptCdsco ppt
Cdsco ppt
 
Common Technical Document
Common Technical DocumentCommon Technical Document
Common Technical Document
 
2. unit II, chapter-2 regulatory authorities and agencies.
2. unit II, chapter-2 regulatory authorities and agencies.2. unit II, chapter-2 regulatory authorities and agencies.
2. unit II, chapter-2 regulatory authorities and agencies.
 
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...
 
Hatch waxman act & amendments ppt
Hatch waxman act & amendments  pptHatch waxman act & amendments  ppt
Hatch waxman act & amendments ppt
 
DMF Drug Master File
DMF   Drug Master FileDMF   Drug Master File
DMF Drug Master File
 
ANDA
ANDAANDA
ANDA
 
hatch-waxman act@amendments
hatch-waxman act@amendmentshatch-waxman act@amendments
hatch-waxman act@amendments
 
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
Unit-III, Chapter 1. Registration of Indian Products in Overseas Market.
 
Supac
Supac Supac
Supac
 
THERAPEUTIC GOODS ADMINISTRATION (TGA) and MHRA
THERAPEUTIC GOODS ADMINISTRATION (TGA) and MHRATHERAPEUTIC GOODS ADMINISTRATION (TGA) and MHRA
THERAPEUTIC GOODS ADMINISTRATION (TGA) and MHRA
 
Anda
AndaAnda
Anda
 
PMS (post marketing surveillance)
PMS (post marketing surveillance)PMS (post marketing surveillance)
PMS (post marketing surveillance)
 
Code of Federal Regulations
Code of Federal RegulationsCode of Federal Regulations
Code of Federal Regulations
 
New drug application
New drug applicationNew drug application
New drug application
 
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATIONCDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION
CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION
 
Pharmaceutical Licecnsing authorites of india
Pharmaceutical Licecnsing authorites of indiaPharmaceutical Licecnsing authorites of india
Pharmaceutical Licecnsing authorites of india
 
4. Unit-IV:- Clinical Trials.
4. Unit-IV:- Clinical Trials.4. Unit-IV:- Clinical Trials.
4. Unit-IV:- Clinical Trials.
 
Generic drugs product development
Generic drugs product developmentGeneric drugs product development
Generic drugs product development
 
5. Unit-V- Regulatory Concepts.
5. Unit-V- Regulatory Concepts.5. Unit-V- Regulatory Concepts.
5. Unit-V- Regulatory Concepts.
 

Similar to The introduction of an orange book

Fixed dose combination products – rationality, status in india, development i...
Fixed dose combination products – rationality, status in india, development i...Fixed dose combination products – rationality, status in india, development i...
Fixed dose combination products – rationality, status in india, development i...Dr Sukanta sen
 
regulatory concepts endfkadflsdjfajfd.ppt
regulatory concepts endfkadflsdjfajfd.pptregulatory concepts endfkadflsdjfajfd.ppt
regulatory concepts endfkadflsdjfajfd.pptomkarborlepwar2002
 
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!Pristyn Research Solutions
 
Brand drug vs generic drug
Brand drug vs generic drugBrand drug vs generic drug
Brand drug vs generic drugShubham Paul
 
Combinational products & medical devices
Combinational products & medical devicesCombinational products & medical devices
Combinational products & medical devicesSHUBHAMGWAGH
 
Anda for generic drugs in Regulatory affairs
Anda for generic drugs in Regulatory affairsAnda for generic drugs in Regulatory affairs
Anda for generic drugs in Regulatory affairsPreranaHusukale
 
Basic concepts about regulatory affairs
Basic concepts about regulatory affairsBasic concepts about regulatory affairs
Basic concepts about regulatory affairsRajkumar Koley
 
Botanical Drug Development
Botanical Drug DevelopmentBotanical Drug Development
Botanical Drug DevelopmentPeter Pekos
 
Fundamental concept of regulatory affairs in pharmaceutical & biotechnology
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyFundamental concept of regulatory affairs in pharmaceutical & biotechnology
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyHitendra Singh
 
3.generic drug product (1) (2)
3.generic drug product (1) (2)3.generic drug product (1) (2)
3.generic drug product (1) (2)FarsanaFiroz1
 
US FDA Regulatory Submissions
US FDA Regulatory SubmissionsUS FDA Regulatory Submissions
US FDA Regulatory SubmissionsChandra Mohan
 
Comparative Study of Dossier Compilation & Submission Process of Drug Product...
Comparative Study of Dossier Compilation & Submission Process of Drug Product...Comparative Study of Dossier Compilation & Submission Process of Drug Product...
Comparative Study of Dossier Compilation & Submission Process of Drug Product...DeveshDRA
 
Pharmaceutical regulatory authorities and agencies
Pharmaceutical regulatory authorities and agenciesPharmaceutical regulatory authorities and agencies
Pharmaceutical regulatory authorities and agenciesChintamBaladattaSai
 
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptx
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptxMRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptx
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptxDimple Marathe
 
schedule y of drugs and cosmetic acts
schedule y of drugs and cosmetic actsschedule y of drugs and cosmetic acts
schedule y of drugs and cosmetic actsarponbiswas
 
Measuring the Relationship between Innovative Drugs and AE_2015
Measuring the Relationship between Innovative Drugs and AE_2015Measuring the Relationship between Innovative Drugs and AE_2015
Measuring the Relationship between Innovative Drugs and AE_2015Jonathan Bryan
 

Similar to The introduction of an orange book (20)

Fixed dose combination products – rationality, status in india, development i...
Fixed dose combination products – rationality, status in india, development i...Fixed dose combination products – rationality, status in india, development i...
Fixed dose combination products – rationality, status in india, development i...
 
Nda
NdaNda
Nda
 
regulatory concepts endfkadflsdjfajfd.ppt
regulatory concepts endfkadflsdjfajfd.pptregulatory concepts endfkadflsdjfajfd.ppt
regulatory concepts endfkadflsdjfajfd.ppt
 
Drug Standards
Drug Standards Drug Standards
Drug Standards
 
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!
 
Brand drug vs generic drug
Brand drug vs generic drugBrand drug vs generic drug
Brand drug vs generic drug
 
Combinational products & medical devices
Combinational products & medical devicesCombinational products & medical devices
Combinational products & medical devices
 
Anda for generic drugs in Regulatory affairs
Anda for generic drugs in Regulatory affairsAnda for generic drugs in Regulatory affairs
Anda for generic drugs in Regulatory affairs
 
Basic concepts about regulatory affairs
Basic concepts about regulatory affairsBasic concepts about regulatory affairs
Basic concepts about regulatory affairs
 
MONOGRAPH.pptx
MONOGRAPH.pptxMONOGRAPH.pptx
MONOGRAPH.pptx
 
Botanical Drug Development
Botanical Drug DevelopmentBotanical Drug Development
Botanical Drug Development
 
Fundamental concept of regulatory affairs in pharmaceutical & biotechnology
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyFundamental concept of regulatory affairs in pharmaceutical & biotechnology
Fundamental concept of regulatory affairs in pharmaceutical & biotechnology
 
3.generic drug product (1) (2)
3.generic drug product (1) (2)3.generic drug product (1) (2)
3.generic drug product (1) (2)
 
US FDA Regulatory Submissions
US FDA Regulatory SubmissionsUS FDA Regulatory Submissions
US FDA Regulatory Submissions
 
Comparative Study of Dossier Compilation & Submission Process of Drug Product...
Comparative Study of Dossier Compilation & Submission Process of Drug Product...Comparative Study of Dossier Compilation & Submission Process of Drug Product...
Comparative Study of Dossier Compilation & Submission Process of Drug Product...
 
Pharmaceutical regulatory authorities and agencies
Pharmaceutical regulatory authorities and agenciesPharmaceutical regulatory authorities and agencies
Pharmaceutical regulatory authorities and agencies
 
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptx
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptxMRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptx
MRA201 T. Unit 1 Regulatory aspects of drugs and cosmetics unit 1.pptx
 
schedule y of drugs and cosmetic acts
schedule y of drugs and cosmetic actsschedule y of drugs and cosmetic acts
schedule y of drugs and cosmetic acts
 
Fda guidance for food and drug labelling professor pirouzi
Fda guidance for food and drug labelling   professor pirouziFda guidance for food and drug labelling   professor pirouzi
Fda guidance for food and drug labelling professor pirouzi
 
Measuring the Relationship between Innovative Drugs and AE_2015
Measuring the Relationship between Innovative Drugs and AE_2015Measuring the Relationship between Innovative Drugs and AE_2015
Measuring the Relationship between Innovative Drugs and AE_2015
 

Recently uploaded

Case Report Peripartum Cardiomyopathy.pptx
Case Report Peripartum Cardiomyopathy.pptxCase Report Peripartum Cardiomyopathy.pptx
Case Report Peripartum Cardiomyopathy.pptxNiranjan Chavan
 
BIOLOGICAL ASSAY OF ANTIBIOTICS , VITAMIN D , DIGOXIN & INSULIN
BIOLOGICAL ASSAY  OF ANTIBIOTICS , VITAMIN D , DIGOXIN  & INSULINBIOLOGICAL ASSAY  OF ANTIBIOTICS , VITAMIN D , DIGOXIN  & INSULIN
BIOLOGICAL ASSAY OF ANTIBIOTICS , VITAMIN D , DIGOXIN & INSULINHasnat Tariq
 
Report Back from SGO: What’s New in Uterine Cancer?.pptx
Report Back from SGO: What’s New in Uterine Cancer?.pptxReport Back from SGO: What’s New in Uterine Cancer?.pptx
Report Back from SGO: What’s New in Uterine Cancer?.pptxbkling
 
Apiculture Chapter 1. Introduction 2.ppt
Apiculture Chapter 1. Introduction 2.pptApiculture Chapter 1. Introduction 2.ppt
Apiculture Chapter 1. Introduction 2.pptkedirjemalharun
 
SWD (Short wave diathermy)- Physiotherapy.ppt
SWD (Short wave diathermy)- Physiotherapy.pptSWD (Short wave diathermy)- Physiotherapy.ppt
SWD (Short wave diathermy)- Physiotherapy.pptMumux Mirani
 
PULMONARY EMBOLISM AND ITS MANAGEMENTS.pdf
PULMONARY EMBOLISM AND ITS MANAGEMENTS.pdfPULMONARY EMBOLISM AND ITS MANAGEMENTS.pdf
PULMONARY EMBOLISM AND ITS MANAGEMENTS.pdfDolisha Warbi
 
Pharmaceutical Marketting: Unit-5, Pricing
Pharmaceutical Marketting: Unit-5, PricingPharmaceutical Marketting: Unit-5, Pricing
Pharmaceutical Marketting: Unit-5, PricingArunagarwal328757
 
Noida Sector 135 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few C...
Noida Sector 135 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few C...Noida Sector 135 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few C...
Noida Sector 135 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few C...rajnisinghkjn
 
Hemostasis Physiology and Clinical correlations by Dr Faiza.pdf
Hemostasis Physiology and Clinical correlations by Dr Faiza.pdfHemostasis Physiology and Clinical correlations by Dr Faiza.pdf
Hemostasis Physiology and Clinical correlations by Dr Faiza.pdfMedicoseAcademics
 
PERFECT BUT PAINFUL TKR -ROLE OF SYNOVECTOMY.pptx
PERFECT BUT PAINFUL TKR -ROLE OF SYNOVECTOMY.pptxPERFECT BUT PAINFUL TKR -ROLE OF SYNOVECTOMY.pptx
PERFECT BUT PAINFUL TKR -ROLE OF SYNOVECTOMY.pptxdrashraf369
 
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptx
COVID-19  (NOVEL CORONA  VIRUS DISEASE PANDEMIC ).pptxCOVID-19  (NOVEL CORONA  VIRUS DISEASE PANDEMIC ).pptx
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptxBibekananda shah
 
POST NATAL EXERCISES AND ITS IMPACT.pptx
POST NATAL EXERCISES AND ITS IMPACT.pptxPOST NATAL EXERCISES AND ITS IMPACT.pptx
POST NATAL EXERCISES AND ITS IMPACT.pptxvirengeeta
 
call girls in paharganj DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in paharganj DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️call girls in paharganj DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in paharganj DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️saminamagar
 
Dwarka Sector 2 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few Cl...
Dwarka Sector 2 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few Cl...Dwarka Sector 2 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few Cl...
Dwarka Sector 2 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few Cl...rajnisinghkjn
 
Glomerular Filtration rate and its determinants.pptx
Glomerular Filtration rate and its determinants.pptxGlomerular Filtration rate and its determinants.pptx
Glomerular Filtration rate and its determinants.pptxDr.Nusrat Tariq
 
Presentation on General Anesthetics pdf.
Presentation on General Anesthetics pdf.Presentation on General Anesthetics pdf.
Presentation on General Anesthetics pdf.Prerana Jadhav
 
Hematology and Immunology - Leukocytes Functions
Hematology and Immunology - Leukocytes FunctionsHematology and Immunology - Leukocytes Functions
Hematology and Immunology - Leukocytes FunctionsMedicoseAcademics
 
Primary headache and facial pain. (2024)
Primary headache and facial pain. (2024)Primary headache and facial pain. (2024)
Primary headache and facial pain. (2024)Mohamed Rizk Khodair
 
call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️saminamagar
 

Recently uploaded (20)

Case Report Peripartum Cardiomyopathy.pptx
Case Report Peripartum Cardiomyopathy.pptxCase Report Peripartum Cardiomyopathy.pptx
Case Report Peripartum Cardiomyopathy.pptx
 
BIOLOGICAL ASSAY OF ANTIBIOTICS , VITAMIN D , DIGOXIN & INSULIN
BIOLOGICAL ASSAY  OF ANTIBIOTICS , VITAMIN D , DIGOXIN  & INSULINBIOLOGICAL ASSAY  OF ANTIBIOTICS , VITAMIN D , DIGOXIN  & INSULIN
BIOLOGICAL ASSAY OF ANTIBIOTICS , VITAMIN D , DIGOXIN & INSULIN
 
Report Back from SGO: What’s New in Uterine Cancer?.pptx
Report Back from SGO: What’s New in Uterine Cancer?.pptxReport Back from SGO: What’s New in Uterine Cancer?.pptx
Report Back from SGO: What’s New in Uterine Cancer?.pptx
 
Epilepsy
EpilepsyEpilepsy
Epilepsy
 
Apiculture Chapter 1. Introduction 2.ppt
Apiculture Chapter 1. Introduction 2.pptApiculture Chapter 1. Introduction 2.ppt
Apiculture Chapter 1. Introduction 2.ppt
 
SWD (Short wave diathermy)- Physiotherapy.ppt
SWD (Short wave diathermy)- Physiotherapy.pptSWD (Short wave diathermy)- Physiotherapy.ppt
SWD (Short wave diathermy)- Physiotherapy.ppt
 
PULMONARY EMBOLISM AND ITS MANAGEMENTS.pdf
PULMONARY EMBOLISM AND ITS MANAGEMENTS.pdfPULMONARY EMBOLISM AND ITS MANAGEMENTS.pdf
PULMONARY EMBOLISM AND ITS MANAGEMENTS.pdf
 
Pharmaceutical Marketting: Unit-5, Pricing
Pharmaceutical Marketting: Unit-5, PricingPharmaceutical Marketting: Unit-5, Pricing
Pharmaceutical Marketting: Unit-5, Pricing
 
Noida Sector 135 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few C...
Noida Sector 135 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few C...Noida Sector 135 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few C...
Noida Sector 135 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few C...
 
Hemostasis Physiology and Clinical correlations by Dr Faiza.pdf
Hemostasis Physiology and Clinical correlations by Dr Faiza.pdfHemostasis Physiology and Clinical correlations by Dr Faiza.pdf
Hemostasis Physiology and Clinical correlations by Dr Faiza.pdf
 
PERFECT BUT PAINFUL TKR -ROLE OF SYNOVECTOMY.pptx
PERFECT BUT PAINFUL TKR -ROLE OF SYNOVECTOMY.pptxPERFECT BUT PAINFUL TKR -ROLE OF SYNOVECTOMY.pptx
PERFECT BUT PAINFUL TKR -ROLE OF SYNOVECTOMY.pptx
 
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptx
COVID-19  (NOVEL CORONA  VIRUS DISEASE PANDEMIC ).pptxCOVID-19  (NOVEL CORONA  VIRUS DISEASE PANDEMIC ).pptx
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptx
 
POST NATAL EXERCISES AND ITS IMPACT.pptx
POST NATAL EXERCISES AND ITS IMPACT.pptxPOST NATAL EXERCISES AND ITS IMPACT.pptx
POST NATAL EXERCISES AND ITS IMPACT.pptx
 
call girls in paharganj DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in paharganj DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️call girls in paharganj DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in paharganj DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
 
Dwarka Sector 2 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few Cl...
Dwarka Sector 2 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few Cl...Dwarka Sector 2 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few Cl...
Dwarka Sector 2 Call Girls ( 9873940964 ) Book Hot And Sexy Girls In A Few Cl...
 
Glomerular Filtration rate and its determinants.pptx
Glomerular Filtration rate and its determinants.pptxGlomerular Filtration rate and its determinants.pptx
Glomerular Filtration rate and its determinants.pptx
 
Presentation on General Anesthetics pdf.
Presentation on General Anesthetics pdf.Presentation on General Anesthetics pdf.
Presentation on General Anesthetics pdf.
 
Hematology and Immunology - Leukocytes Functions
Hematology and Immunology - Leukocytes FunctionsHematology and Immunology - Leukocytes Functions
Hematology and Immunology - Leukocytes Functions
 
Primary headache and facial pain. (2024)
Primary headache and facial pain. (2024)Primary headache and facial pain. (2024)
Primary headache and facial pain. (2024)
 
call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
 

The introduction of an orange book

  • 1. THE INTRODUCTION OF AN ORANGE BOOK
  • 2. DEFINITIONS  It is the publication of “Approved Drug Products with Therapeutic Equivalence Evaluations” by the Food and Drug Administration.  It is prepared by The Orange Book Staff, Center for Drug Evaluation and Research.  It identified drug products on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetics Act.  Drugs marketed only on the basis of safety or pre-1938 drugs.
  • 3. CONTD..  The list is independent of any current regulatory action against a drug product.  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.  The FDA does not recommend substituting drugs that have not been determined to be bioequivalent.  Drugs that are not listed as bioequivalent should not be substituted for each other.
  • 4. HISTORY 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 January, 1979 The list was distributed (included only currently marketed prescription drug products approved by FDA through NDAs and ANDAs under the provisions of section 505 of the Act) October 31, 1980 The final rule (includes FDA’s response to the public comments on the proposal) was published in the Federal Register (45 FR 72582). The list incorporated appropriate corrections and additions.
  • 5. OBJECTIVES To allow review of patterns of access and usage To allow discovery of use of unusual privileges To allow discovery of repeated attempts to bypass protections To serve as a deterrent by its existence To supply an additional form of user assurance
  • 6. CONTENTS OF ORANGE BOOK 1. INTRODUCTION 1.1 Content and Exclusion 1.2 Therapeutic Equivalence-Related Terms 1.3 Statistical Criteria for Bioequivalence 1.4 Reference Listed Drug 1.5 General Policies and Legal Status 1.6 Practitioner/User Responsibilities 1.7 Therapeutic Equivalence Evaluations Codes 1.8 Description of Special Situations 1.9 Therapeutic Equivalence Code Change for a Drug Entity 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
  • 7. CONTENTS 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
  • 8. CONTENTS 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
  • 9. APPENDICES • Product Name Index A-1 • B. Product Name Index Listed by • C. Uniform Terms PATENT AND EXCLUSIVITY INFORMATION ADDENDUM A. Patent and Exclusivity Lists B. Patent and Exclusivity Terms