FDA Offers Guidance for Choosing Prescription Drug Names


If you've seen your share of prescription drug commercials, you've likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations of letters, but naming a drug requires more than a marketing brainstorm session. A recent draft guidance document from the U.S. Food and Drug Administration ("FDA") shows many considerations go into choosing a drug name. Names that are too similar can be confused, and names that include descriptive phrases or abbreviations could be misunderstood, leading to unfair marketing and drug errors. In order to improve safety and reduce ambiguous or misleading names, the FDA suggests that drug makers follow the nonbinding guidelines in the guidance document. The guidelines advise:

  • Avoid similarities in spelling or pronunciation with names of other drugs, even if those other drugs are discontinued or only sold in foreign countries.
  • Avoid including medical abbreviations within the name. For example, the NameQD could be mistaken on a prescription for the medical abbreviation QD, or quaque die in Latin, meaning every day.
  • Avoid using the same proprietary name or the same root proprietary name for products that do not contain at least one common active ingredient.
  • Avoid names that include product-specific attributes, dosage form, or route of administration. (NameOral, Nametabs, etc.)
  • Avoid non-standard suffixes or modifiers that could cause confusion. For example, Name3 could be misunderstood as a drug to be taken for 3 days or a drug that includes 3 active ingredients.
  • Avoid using different names for products with identical active ingredients.  Unaware prescribers could put a patient on both at the same time, possibly causing overdose.
  • Avoid fanciful names that state or imply a quality of the drug, such as BestMed or DrugSuper.
  • Avoid symbols. For example, if a drug is called Name+, the plus sign could be confused on a prescription pad for "and" or the number 4.

Knowing these naming constraints exist, the next time you see a drug commercial, you'll realize that a new drug name might sound arbitrary, but it definitely isn't.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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