FDA and CDER have launched a mobile application (app) to put timely information about generic drugs in the hands of those using smartphones and tablets. The new app makes it easy and convenient to view The Approved Drug Products with Therapeutic Equivalence Evaluations list. This list is most commonly known as the “Orange Book.”
The Orange Book Express mobile app provides users with a mobile-friendly way to identify drug products approved on the basis of safety and effectiveness by the Agency, as well as information about patents and exclusivity. It allows them to search both the Active Ingredient and Proprietary Name fields at once, without searching separately for each marketing status for prescription, over-the-counter, and discontinued products. Users can also search by patent number without specifying a marketing status. The app will differ from the full Web version of the Orange Book in that the ability to filter results and search for text within results will be unavailable via data download.
Orange Book users include pharmacists, prescribers, industry, Agency employees, and third-party payers. Industry personnel refer to the Orange Book for its patent pages and product-specific exclusivity information, and to determine reference standards or drugs for performing their bioequivalence studies. Third-party payers, pharmacists, and prescribers use the Orange Book to determine appropriate generic drug substitution.
The Orange Book first appeared as a print publication in October 1980. Today “Orange Book” is one of the most searched-for terms on FDA.gov.
The Orange Book Express mobile app reflects our commitment to keep up with the latest technologies, developing effective means for the public to access important and useful information about generic drugs. The app also makes the Orange Book available to a wider audience than ever before – supporting users who may not always have convenient access to a computer or wired Internet connection.
I would like to sincerely thank the Office of Generic Drugs and the Office of Communications for their innovative efforts to bring us to another significant milestone in generic drug history. As a result of their work, easy access to real-time information about generics is available. This is especially important for health care professionals who rely on this information in protecting their patients’ health and providing consumers with alternatives to brand name drugs.
For more information about the new mobile app, including links for free download via iTunes or Google Play Store, visit Orange Book.
Janet Woodcock
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Download the New Orange Book ExpressMobile Application! 
Searching the Orange Book is now faster and easier with our new mobile app!
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About the Orange Book
The Orange Book is 35 Years Old!
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). (For more information, see the Orange Book Preface.)
The Approved Drug Products list first appeared as a print publication in October 1980. With the 25th edition (2005), Portable Document Format (PDF) versions of the Annual Edition and the Cumulative Supplement became available.
The Orange Book Search was added to the FDA website October 31, 1997.
To send comments or questions about the Orange Book or drug data, please see the contact information below.
- Orange Book Search
You can search by active ingredient, proprietary name, applicant, application number, or patent number.
Orange Book Publications
Orange Book Annual Edition (PDF - 7.3MB)
35th Edition - The publication identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.Orange Book Current Cumulative Supplement (PDF - 1.2MB)
The monthly Cumulative Supplement publication provides information on newly approved drugs, changes and revisions to current data including therapeutic equivalence evaluations, and updated patent and exclusivity data.- Additions/Deletions for Prescription and OTC Drug Product Lists
Changes to the annual edition are listed separately by month.
Downloadable Files
- About the Orange Book Data Files
Descriptions of data fields in the Web version of the Orange Book. - Orange Book Data Files (compressed) (ZIP - 614KB)
Download the file. Updated monthly. - Appendix A: Product Name Index (PDF - 134KB)
Prescription and OTC drug product lists. An index of drug products by established or trade name. Updated quarterly. - Appendix B: Product Name Sorted by Applicant (PDF - 516KB)
Product Name Index Listed by Applicant (prescription and OTC product lists). Cross-references applicants to drug products. Updated quarterly. - Appendix C: Uniform Terms (PDF - 97KB)
Uniform terms used to designate dosage forms and routes of administration; abbreviations used to designate strengths.
Help and Background Information
- Electronic Orange Book Video
FDA Drug Info Rounds pharmacists discuss how to search the Electronic Orange Book for generic equivalents, patents, and exclusivity. - Frequently Asked Questions on The Orange Book
- Frequently Asked Questions on Patents and Exclusivity
- Orange Book Preface
The Orange Book downloadable data files are updated monthly. We make every effort to prevent errors and discrepancies in the Approved Drug Products data files; however, if you wish to report an error or discrepancy in drug data, please send a brief description of the problem to: orangebook@fda.hhs.gov.
General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information:druginfo@fda.hhs.gov
Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information (FOIA) Staff.
All FOIA requests must be in writing. At this time, FDA does not accept FOIA requests sent via e-mail. Requests should be mailed to the following address:
Food and Drug Administration
Division of Freedom of Information
Office of Shared Services
Office of Public Information and Library Services
12420 Parklawn Drive
ELEM-1029
Rockville, MD 20857
Requests may be sent via fax to: fax number (301) 827-9267.
If you experience difficulty sending a fax, please call (301) 796-3900.
The CDER Freedom of Information Office Electronic Reading Room page provides background information about the FOIA process.
General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information:druginfo@fda.hhs.gov
Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information (FOIA) Staff.
All FOIA requests must be in writing. At this time, FDA does not accept FOIA requests sent via e-mail. Requests should be mailed to the following address:
Food and Drug Administration
Division of Freedom of Information
Office of Shared Services
Office of Public Information and Library Services
12420 Parklawn Drive
ELEM-1029
Rockville, MD 20857
Requests may be sent via fax to: fax number (301) 827-9267.
If you experience difficulty sending a fax, please call (301) 796-3900.
The CDER Freedom of Information Office Electronic Reading Room page provides background information about the FOIA process.
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