Thursday 3 November 2011

Orange Book


What is Orange Book?
  • It is the commonly used name for the book “Approved Drug Products with Therapeutic Equivalence Evaluations”, which is published by USFDA.
  • It contains the list of 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.
  • FDA was required to publish orange book under Drug, Price and Competition Act (1984) which is also known as Hatch-Waxman Act

Orange book doesn’t cover-
  • Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal Tablets and  Librax Capsules]
  • Pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication. 

Other important facts-
  • The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.
  • Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product.
  • The List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs.
  • Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act.

We can search all the orange book listed approved drug products in the FDA’s website by using any of the following search options
  • Search by Active Ingredient
  • Search by Applicant Holder
  • Search by Proprietary Name
  • Search by Application Number
  • Search by Patent

Keywords: Approved Drug Products with Therapeutic Equivalence Evaluations, Orange Book, Drug, Price and Competition Act or Hatch-Waxman Act, DESI.



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