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Frequently asked Questions on The Orange Book
How often is the Orange Book updated?
How do I obtain Orange Book information?
How Do I use the Electronic Orange Book to find approved generic drugs?
I
want drug information not found in the Orange Book. How do I go about getting it?
1. How
often is the Orange Book updated?
Since February 2005, we have been providing daily Electronic Orange Book (EOB)
product information for new generic drug approvals. Daily generic
updates provide the consumer with the current list of approved generic
products which is important for substitution purposes. Previously, a
first-time-generic product approved early in the month would not be
published in the EOB for several weeks.
The
monthly EOB update goal is by the end of the following month’s
second work week (e.g., November’s EOB will be updated by the end of
the second full work week in December).
The
EOB content includes:
(Discontinued products will be processed as of the date of
publication. There will be circumstances where a product
is discontinued in one month, however, it will be reported in a
different month's EOB. For example, the Orange Book
Staff received a letter November 7 that the product has
been discontinued from manufacturing and marketing. The
Orange Book subsequently updates the October EOB on November
14. The product will show in the October EOB that it is
discontinued even though the date of discontinuance is the day
that the Orange Book Staff receives notification (November 7)).
-
New
Drug Application (NDA) approvals (20,000 and 50,000 series) in the EOB month they were approved.
-
Patent information, also updated daily in the EOB, as of
the date of the daily update.
-
Exclusivity information updated monthly and current to the date
of the monthly EOB update date.
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2. How do
I obtain the Orange Book?
Commencing with the 25th edition, the Annual Edition and monthly Cumulative
Supplements have been provided in downloadable Portable Document
Format (PDF) at the EOB home page by clicking on Annual Edition. The PDF
annual and cumulative supplements duplicate previous paper versions.
Over time, there will be an archive for the annuals and each year's
December Cumulative Supplement.
The downloaded Annual Edition and Cumulative Supplements are also
available in a paper version (Approved Drug Products with Therapeutic
Equivalence Evaluations, ADP) from the U.S. Government Printing
Office: http://bookstore.gpo.gov/
; toll free 866-512-1800/
There are ASCII text files of the Orange Book drug product, patent, and
exclusivity data at
http://www.fda.gov/cder/orange/obreadme.htm . The text files are
provided in eobzip.exe and eobzip.zip format. The files are updated
concurrently with the monthly cumulative supplements. Also, the annual
Orange Book Edition Appendices A, B, and C in PDF format are updated
quarterly.
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3. How Do I
use the Electronic Orange Book to find approved generic drugs?
First, if you have the trade name, search the Electronic Orange Book Rx or OTC section
using the Proprietary Name search. This determines the ingredient(s).
Then use the Ingredient Search for all approved products that contain the ingredient(s). The resulting list will provide approved products by dosage form and route.
For each
dosage form; route grouping, there will be a Reference Listed Drug (RLD) that is the
innovator product. One or more strengths will have a Yes RLD. If there are approved
generic products of another firm, the RLD will be No and all the products within the
dosage form; route grouping will have a therapeutic Equivalence Code (TE Code). Products
that have been discontinued are in the Discontinued Section and do not RLD or TE Codes. The OTC Section products are not evaluated for therapeutic Equivalence.
Refer to the EOB home page
preface for discussion and definitions of the TE Code and Reference Listed Drug (RLD). There is also a link on the query column headings which will link to the definition of
these terms.
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4.
I want drug information not found in the Orange Book. How do I go about getting it?
Requests for more specific information may be obtained via the Freedom of Information Act. Requests should be submitted in writing or directed to the FDA's Freedom of Information
Staff at:
Food and Drug Administration
Freedom of Information Office, HFI-35
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 827-6500
The CDER Freedom of Information Office
Electronic Reading Room also has additional information available.
A Handbook for Requesting
Information and Records from FDA is also available.
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Orange Book
Date created: March 8, 2001, Updated: October 26, 2006 |
