March 13, 2018
Authored and Edited by Jessica L.A. Marks; B. Brett Heavner
On March 9, 2018, FDA issued draft guidance on Proprietary Names for New Animal Drugs. The draft guidance is intended to assist new animal drug sponsors to select proprietary drug names that comply with the Center for Veterinary Medicine’s requirements.
The Center for Veterinary Medicine already evaluates proprietary names in NADA as part of the approval process. The names of new animal drugs, for example, must not have similar spellings or pronunciations to either human medications or veterinary medications of other companies. Nor should the names be misleading, for example, by suggesting ingredients, dosage, or delivery that could cause or contribute to medication errors. The draft guidance explains the Center for Veterinary Medicine’s process and provides guidance for NADA sponsors so that chosen names may comply with the criteria upon submission. The FDA is accepting public comments on the draft from March 12, 2018 to May 11, 2018.
Readers are encouraged to read the draft guidance, also available on FDA’s website.
veterinary pharmaceuticals, Food and Drug Administration (FDA), FDA Guidance, New Animal Drug Application (NADA)
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