Emgality ® (galcanezumab-gnlm) injection

100 mg/mL, 120 mg/mL

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

What does the suffix "gnlm" mean after galcanezumab in the Emgality® (galcanezumab-gnlm) package insert?

The suffix "gnlm" added to galcanezumab does not have any clinical meaning.

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Food and Drug Administration Guidance

The suffix assigned to galcanezumab, -gnlm, is a Food and Drug Administration (FDA)-designated suffix applicable in the United States only. The FDA issued guidance in 2017 regarding the addition of 4-letter suffixes to the end of the core name of newly approved biologics.1 

The suffixes

  • are unique to each core name
  • have no meaning
  • consist of 4 lower-case letters, of which at least 3 are distinct
  • are nonproprietary
  • are attached to the core name via hyphen, and
  • are free from usage-restricting legal barriers.1

According to the FDA, the suffix can

  • serve as a key element to identify specific products in spontaneous adverse event reporting
  • help to avoid the inaccurate perception of safety and efficacy based on licensure pathway
  • minimize inadvertent substitutions that are not interchangeable, and
  • reinforce accurate product identification in prescribing, billing, and claims records used for active pharmacovigilance.1

Reference

1US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Nonproprietary naming of biological products: guidance for industry. January 2017. Accessed November 10, 2021. https://www.fda.gov/downloads/drugs/guidances/ucm459987.pdf

Date of Last Review: November 10, 2021


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