About FDA

Does FDA approve the proprietary names of prescription drugs?

Yes.  New prescription drugs approved by FDA have both a scientific name, known as the generic (also called the established name), and a name given by the manufacturer, known as the proprietary name (also called the brand name or trade name).  Before a drug is approved by FDA, the Agency will carefully review the proposed proprietary name. 

It is important for safety reasons that the written proprietary name not look like that of another proprietary name nor sound like another proprietary name when spoken.  If there is similarity between the proprietary name of a new prescription drug and the proprietary name of an existing drug, a mix-up could occur in ordering and a patient could receive one drug instead of the other. 

FDA’s Division of Medication Error Prevention and Analysis is responsible for proprietary name review prior to approval in the Center for Drug Evaluations and Research.  If a company submits a name that is too similar to another name, FDA will require the company to select another name, for safety reasons, as part of the approval process.   

Page Last Updated: 10/19/2015
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