miércoles, 25 de enero de 2017

Drug Approvals and Databases > Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

Drug Approvals and Databases > Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

The U.S. Food and Drug Administration (FDA) today introduced an important data update to Approved Drug Products with Therapeutic Equivalence Evaluations – known as the “Orange Book.” Search results and drug listings now clarify which listed drugs are reference listed drugs (RLDs) and which are reference standards. Listings also indicate which products in the Discontinued Section may be referred to as an RLD. The FDA made these modifications to reflect recent clarifications published in the draft guidance for industry “Referencing Approved Drug Products in ANDA Submissions.” The print edition of the Orange Book also reflects these updates; the Orange Book mobile app will be updated in the near future.

These updates will help applicants submitting an abbreviated new drug application (ANDA) to seek approval of a generic drug to identify:
  • an RLD, i.e., a previously approved drug product for which an applicant may seek approval of a generic drug;
  • a reference standard, i.e., the previously approved drug selected by FDA that an applicant must use in the conduct of in vivo bioequivalence studies required for approval of an ANDA; and
  • the basis of submission for the ANDA.
Further information is available in the pre-recorded webinar, “Referencing Approved Drug Products in ANDA Submissions.”
The Orange Book, which identifies drug products approved by the FDA, first appeared as a published list in October 1980. Since 1984, the Orange Book has also included information about patents and exclusivity for listed products. In 1997, the FDA made the Orange Book database available for searching on the Web. Today, “Orange Book” is one of the most searched-for terms on FDA.gov.

Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

The Orange Book

PLEASE NOTE: On January 25, 2017, The Orange Book reference standard and RLD data were updated - details here.

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (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) and related patent and exclusivity information. For more information on the Orange Book including its history, see the Orange Book Preface.
Search the Orange Book Database
Search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number.

FDA’s Orange Book Web Search Has a New Look and New Features!

Orange Book 2.0  New Look, New Features
 Searching the Orange Book is now faster and easier with our new mobile app!
Download Orange Book Express
 Download iOS App Download Android App Black

Orange Book Publications

Additional Resources

Contact Us

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.

No hay comentarios:

Publicar un comentario