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The Generic Animal Drug and Patent Restoration act requires that each sponsor of an approved animal drug must submit to the FDA certain information regarding patents held for the animal drug or its method of use. The Act requires that this information, as well as a list of all animal drug products approved for safety and effectiveness, be made available to the public. This list must be updated monthly under the provisions of the Act.
The list, known as the "Green Book," was first published in January 1989. Updates have been added monthly since then. Each January, the list is published in its entirety. The book is published on a non-profit basis from information in a database maintained under a cooperative agreement between the U.S. Department of Agriculture and the Virginia Polytechnic Institute and State University, and funded through an interagency agreement between the FDA and the USDA. The current year Green Book is available in print form by subscription. The electronic Green Book is being developed to improve public access to the information contained in the databases that support its publication. The Web Site formerly known as the "FDA Approved Animal Drug Database" was a derivative of these databases. The initial offering of the electronic Green Book by the Drug Information Laboratory includes the "FDA Approved Animal Drug Database" files, all chapters of the printed Green Book and a searchable archive of monthly updates dating back to 1989.
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