The U.S. Food & Drug Administration issued May 29 the final version of "Guidance for Industry #240: Proprietary Names for New Animal Drugs," which includes revisions to some definitions and minor editorial changes from the draft guidance issued in March 2018.
Previously, FDA said the guidance was meant to provide recommendations to assist sponsors in developing proprietary names for new animal drugs in order to avoid contributing to medication errors, negatively affecting safe use of the drug or misbranding the drug.
The guidance proposes a framework for evaluating proposed proprietary names before submitting them for review by the FDA’s Center for Veterinary Medicine. The guidance also explains how new animal drug sponsors can request agency evaluation of a proposed proprietary name, FDA said.
FDA evaluates proprietary names as part of the new animal drug approval process. Selecting a proprietary name is a critical element in the design and development of animal drug product labeling because end users (the prescribing veterinarian, veterinary technician, food animal producers, animal owners, pharmacist or pharmacy technician) may rely, in part, on the proprietary name to identify which product, among thousands of available products, is intended for a given animal, the agency explained in 2018. If end users cannot readily distinguish among proprietary names, the animal might receive an incorrect product or it might be difficult to correctly identify the product used.
FDA also considers whether the proprietary name can contribute to medication errors. Examples of medication errors include incorrect drug selection, incorrect dosage or route of administration or use in unintended species or classes. These types of errors may cause animal injury or lead to a lack of drug effectiveness, which could contribute to outcomes like complication of a disease and possible death of an animal.