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Best Practices in Developing Proprietary Names for Human Prescription Drug Products Guidance for Industry.

Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 2020.

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December 23, 2020

Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 2020.

Look-alike and sound-alike names weaken the safety of medication use. This guidance provides a structure for industry to reduce instances of drug name similarities and describes the US Food and Drug Administration (FDA) vetting process for drug names to improve naming actions prior to submission to the agency.

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Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 2020.