An overview of the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations.
An overview of the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations.
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FDA 出版物《批准的药物产品与治疗等效性评估》的概述。
DOI：
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发表时间：
1990
期刊：
影响因子：
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通讯作者：
Robert J. Tonelli
中科院分区：
文献类型：
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作者：
J. Knoben;George R. Scott;Robert J. Tonelli
描述了FDA批准的具有治疗等效性评价的药品（“橙子书”）的历史、目的和内容。当20世纪70年代建立的医疗保险报销成本指导方针促使大多数州允许仿制药产品选择时，需要一个可互换药品的官方清单。确定生物利用度和生物等效性的法规于1977年发布，FDA于1980年首次发布批准的药品。橙子手册包括已经过FDA安全性和有效性全面审查的产品，以及已经批准的新药申请（NDA）或简化新药申请（ANDA）和抗生素特殊申请（从5s或6s开始）。根据1984年的《药品价格竞争和专利期限恢复法》，FDA将批准的非处方药产品沿着有关专利和市场独占期的信息添加到橙子书中。还提供了孤儿药产品和某些测试和应用程序。橙子手册中仅提供了含有相同活性成分的多批次处方药产品的等效性评价，并且当在标签规定的条件下给予患者时，预期具有相同的临床效果。根据FDA标准，使用编码系统表示产品的等效性评价，并包括产品名称和制造商的索引。每月发放累积补助金。橙子书包含公共信息和建议，但它不是官方的国家纲要; FDA对药剂师选择药品的国家监管没有立场。等效性评价并不能免除从业人员根据患者的个体需求开药和分发产品时的谨慎。
The history, purpose, and content of FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") are described. When cost guidelines established in the 1970s for Medicare reimbursement prompted most states to permit generic drug product selection, an official list of interchangeable drug products was needed. Regulations for determining bioavailability and bioequivalence were published in 1977, and FDA first published Approved Drug Products in 1980. The Orange Book includes products that have been fully reviewed by FDA for both safety and effectiveness and for which new drug applications (NDAs) or abbreviated new drug applications (ANDAs) and special applications (From 5s or 6s) for antibiotics have been approved. Pursuant to the 1984 Drug Price Competition and Patent Term Restoration Act, FDA added approved nonprescription products to the Orange Book along with information about patents and periods of marketing exclusivity. Orphan drug products and certain testing and application procedures are also provided. Equivalence evaluations are provided in the Orange Book only for multisource prescription drug products that contain the same active ingredients and can be expected to have the same clinical effect when administered to patients under the conditions specified in the labeling. A coding system is used to indicate the products' equivalence evaluations according to FDA criteria, and indexes by product name and manufacturer are included. Monthly Cumulative Supplements are issued. The Orange Book contains public information and advice, but it is not an official national compendium; FDA has no position on state regulation of drug product selection by pharmacists. The equivalence evaluations do not relieve practitioners from exercising care in prescribing and dispensing products according to patients' individual needs.