What Is the FDA Orange Book?

The Food and Drug Administration's Orange Book is a list of drugs approved under section 505 of the Federal Food, Drug and Cosmetic Act for interstate commerce within the United States. The Orange Book is updated daily with new generic drug approvals. Keeping consumers current on approved drugs is essential to the issuance of alternate drugs in the event that substitutes have to be prescribed.

Background

• State laws encourage the prescription of generic drugs in order to minimize state wide drug costs. In order to provide states with a list of drugs approved for safety and effectiveness, the Orange Book was created by the Food and Drug Administration, as well as therapeutic equivalence determinations for multisource drugs which are available from more than one manufacturer.

Types of Approved Drugs

• Approved drugs are placed into four categories. One category of drug is those prescription drugs with therapeutic equivalence evaluations. Over-the-counter drugs that may not be marketed without new drug application approvals or abbreviated new drug application approvals make up a second category of drug. A third category includes drugs administered by the Center for Biologics Evaluation and Research under Section 505 of the Food, Drug and Cosmetic Act. The final category is a list of approved drugs that have not reached the marketing stage, are for military use, exportation or have been discontinued from marketing.

Search

• The FDA provides an electronic search engine known as the Electronic Orange Book (EOB) that allows users to search for Orange Book drugs by associated drug publications, drug proprietary names, active ingredients, patent numbers, pharmaceutical applicant names, and application numbers.

EOB Content

• In addition to the obvious list of FDA approved drugs, the EOB contains new application approvals documented by month, daily updates of abbreviated new drug application approvals and patent approvals and monthly updates of product changes and exclusivity information.

Change Orange Book Information

• Pharmaceutical applicants that want to make changes to Orange Book drug information may submit notifications by snail mail, email or fax to:

  FDA/CDER Orange Book Staff
  Office of Generic Drugs, HFD-610
  7500 Standish Pl.
  Rockville, MD 20855-2773
  [phone]
  [email protected]