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 do the letters -gnlm mean in EMGALITY® (galcanezumab-gnlm)?

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

Detailed Information

The suffix assigned to galcanezumab, -gnlm, is an 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 non-proprietary

  • 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

Enclosed Prescribing Information

EMGALITY® (galcanezumab-gnlm) injection, for subcutaneous use, Lilly

References

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1. FDA U.S. Food and Drug Administration website. Nonproprietary Naming of Biological Products Guidance for Industry. https://www.fda.gov/downloads/drugs/guidances/ucm459987.pdf. Accessed February 5, 2019.

Glossary

FDA = Food and Drug Administration

Date of Last Review: February 04, 2019

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