Know About FDA Orange BookPosted by: Damon Webster | Posted on: December 29, 2020
Indeed, the Orange Book is an official list of US Food and Drug Administration (FDA) approved drugs with therapeutic equivalents.
The Orange Book is published by the FDA Center for Drug Evaluation and Research (CDER). The list includes therapeutic equivalence ratings for several approved prescription drugs. You can use FDA orange book search to know more about drugs in the market.
The review of the common drugs on the list is intended to educate and advise doctors, pharmacists, and health authorities, and help promote access to cheaper drugs.
The Orange Book is divided into four sections: The first contains approved prescription drugs with a therapeutic equivalence rating. Part 2 contains a list of over the counter (OTC) drugs approved for drugs that should not be marketed without an NDA or YOU because they are not covered by existing OTC monographs.
The third section covers medicines administered by the Organic Products Research and Evaluation Center. The fourth section contains a list of approved products that have never been placed on the market, intended only for export, intended for military purposes, have been suspended or withdrawn for reasons other than safety or efficacy.
The therapeutic equivalence ratings included in the list are based on FDA criteria for approved drugs from multiple sources. Notes are displayed in code letters according to the type of note used. For a description of these codes, see the introduction to the list.
The main criterion for listing a drug is that it has received an effective approval that has not been withdrawn for reasons of effectiveness, safety or effectiveness. Inclusion of a product on the list does not depend on current official action at the administrative or judicial level against medicinal products.