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Regulatory Focus™ > News Articles > What Should a New Drug be Named? FDA Gives Industry More Time to Weigh in on Proposed Changes

What Should a New Drug be Named? FDA Gives Industry More Time to Weigh in on Proposed Changes

Posted 14 August 2014 | By Alexander Gaffney, RAC

What Should a New Drug be Named? FDA Gives Industry More Time to Weigh in on Proposed Changes

US regulators are giving the pharmaceutical industry more time to weigh in on a draft guidance released in May 2014 that seeks to establish how new drug products are given their "brand" names.


The proprietary name for a drug is its "brand" name. For example, the erectile dysfunction drug sildenafil is marketed by Pfizer under the brand name "Viagra." In many cases, the brand name is easier to understand and recall for consumers and healthcare providers alike.

However, because brand names are generally shorter than the established non-proprietary name for a drug, it can be easier to get them confused with one another.

One example of this confusion was highlighted in the New England Journal of Medicine in May 2013, where researchers noted that many drugs approved in the last few years have started with the letters ”X” and “Z,” potentially confusing patients. To name a few from the last few years: Xofigo, Xtandi, Xarelto, Xalkori, Xgeva, Zaltrap, Zytiga, Zelboraf, Zioptan, and Zometa.

FDA regulators try to reduce the potential for confusion by approving final trade names submitted by companies, assessing them for similarity to other names. For example, if a company requested a proprietary name of "Simplus," but a similar drug was named "Simplos," regulators would almost certainly reject it based on the potential for mix-ups and errors.

New Guidance

In May 2014, FDA issued a new draft guidance document, Best Practices in Developing Proprietary Names for Drugs, intended to establish the process by which companies should name their drugs in order to prevent confusion between the new drug and other existing drugs.

Among the key points included in the guidance:

  • Sponsors should avoid proprietary names which have "obvious similarities in spelling and pronunciation" to other, already-marketed drugs.
  • Proprietary names should not incorporate medical abbreviations, as this could "inadvertently be a source for error."
  • The name should "not include or suggest the name of one or more, but not all, of its active ingredients," as this can mislead the user into thinking the drug only has one of the drug ingredients in it.
  • Names should not incorporate US Adopted Name (USAN) stems, as those designate a pharmacological or chemical trait of a drug, and are not unique (and can therefore lead to confusion).
  • Proprietary names or the same root proprietary name should not be shared among products, even if owned by the same company, if they don't contain at least one common active ingredient contained in the original marketed product.
  • Discontinued names should not be reused.

In addition, FDA said it would formally recommend that sponsors conduct real-world "simulation studies" to eliminate potential errors (such as confusion caused by messily-written prescriptions) and computational analysis of drug name similarity (known as POCA) to further eliminate potential similarities. (More on the guidance here.)

More Time to Comment

But now, after several months and requests for additional time, FDA has announced that it will give companies more time in which to comment on the draft guidance before it is considered for implementation.

Boehringer Ingelheim, the Consumer Healthcare Products Association (CHPA) and Procter & Gamble had all requested additional time to comment, according to FDA records.

Companies will now have an additional 30 days—until 15 September 2014—to comment on the guidance.


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