About FDA

FDA Basics Webinar – November 12, 2015: Generic Drugs and FDA’s Orange Book

Generic drugs approved by FDA have the same high quality, strength, purity, and stability as their brand-name counterparts. Generics provide safe and effective alternatives to brand-name drugs at lower costs due to an abbreviated approval pathway introduced in the 1980s. This abbreviated new drug application (ANDA) process eliminates repetition of the very expensive clinical safety and efficacy studies as well as pre-clinical animal studies, allowing manufacturers to bring a generic copy to market at a significantly reduced cost.

In order for there to be generic drugs, there must first be an approved innovator or brand-name drug to copy. All brand-name (“innovator”) products are approved by FDA on the basis of safety and effectiveness demonstrated by extensive pre-clinical and clinical studies. Generic drug manufacturers use the brand-name to guide the development of their products. According to the Hatch-Waxman Amendments, a generic drug must not show any “significant difference” from the brand-name. This way, FDA can rely on the finding of safety and effectiveness of the brand-name as evidence that the generic version will also be safe and effective.

The Approved Drug Products with Therapeutic Equivalence Evaluations publication (the List, commonly known as the Orange Book) provides information on drug products approved as safe and effective under the Federal Food Drug and Cosmetic Act. The Orange Book first appeared as a print publication in 1980 and celebrated its 35th anniversary on October 30, 2015. An online version of the Orange Book was added to the FDA website on October 31, 1997, and the FDA recently announced the availability of the Orange Book Express mobile app.
In this webinar, CDR Kendra Stewart, R.Ph., Pharm.D. (USPHS) and acting Supervisor of the Orange Book Staff talks about generic drugs and how FDA works to assure they are as safe and effective as their brand-name counterparts. CDR Stewart will also describe the Orange Book and how health care professionals and other stakeholders can use this tool and its new mobile app to access information about generic drugs.
Presenter: CDR Kendra Stewart R.Ph., Pharm.D. (USPHS), (Acting) Supervisor, Orange Book Staff


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