FDA, Turuncu Kitap’ın 33. baskısını yayımlıyor (İng)



FDA Publishes 33rd Edition of Orange Book

The FDA has published its 33rd edition of the Orange Book. The book is widely used in the regulatory community for identifying which drug products are substitutable for one another. The book contains all drug products that are approved or have not been withdrawn for reasons of safety or efficacy with the exception of products marketed before 1938 (pre-Federal Food, Drug And Cosmetic Act) or products approved solely on the basis of their safety (such as those approved through FDA’s Drug Efficacy Study Implementation). 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of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.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. In addition, 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. 

The List is composed of four parts: (1) approved prescription drug products with therapeutic equivalence evaluations; (2) approved over-the-counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under  existing OTC monographs; (3) drug products with approval under Section 505 of the Act administered by the Center for Biologics Evaluation and Research; and (4) a cumulative list of approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing.  This publication also includes indices of prescription and OTC drug products by trade or established name (if no trade name exists) and by applicant name (holder of the approved application). All established names for active ingredients generally conform to official compendial names or United States Adopted Names (USAN) as prescribed in (21 CFR 299.4(e)). The latter list includes applicants’ names as abbreviated in this publication; in addition, a list of uniform terms is provided. 

An Addendum contains drug patent and exclusivity information for the Prescription, OTC, Discontinued Drug Product Lists, and for the Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research. The publication may include additional information that the Agency deems appropriate to disseminate. 

The book identifies products that are both therapeutically equivalent and therapeutically similar. Products that are coded as “A” (AA, AN, AO, AP, AT or AB) are known to FDA to be therapeutically equivalent, having no known or unresolved bioequivalence issues. Products that are coded in the Orange Book as “B” (BC, BD, BE, BN, BP, BR, BS, BT, BX) are not therapeutically equivalent, and either have bioequivalence issues that are known or issues that remain unresolved (but potentially resolvable, which would allow them to be coded as AB).