FDA Issues Guidance on Proprietary Names

April 8, 2016
BioPharm International Editors

The FDA guidance describes information to provide to the agency when submitting a proposed proprietary name.

On April 5, 2016, FDA published guidance describing the information the agency uses in the review process for proposed proprietary names for certain drugs, including biologics. The guidance is intended to help industry in submitting a complete package of information for the assessment of safety aspects and labeling issues associated with a proposed proprietary name.  The guidance applies to prescription drug products that are the subject of an investigational new drug application (IND), a new drug application (NDA), an abbreviated new drug application (ANDA), or a biologics license application (BLA), and nonprescription drug products that are the subject of an IND, NDA, or ANDA.

In the guidance, FDA states that each submission should be identified as either a request for proprietary name review, amendment to request for proprietary name review, or request for reconsideration of proprietary name. IND submissions should include FDA Form 1571; NDA, ANDA, or BLA submissions should include Form 356h.

The submissions should include the following information:

  • Primary and Alternate Proposed Proprietary Name-up to two proposed proprietary names can be included for review and the applicant should specify which is their first choice. FDA will not evaluate the alternate name unless the primary name is found to be unacceptable and the applicant or sponsor has confirmed in writing to the appropriate center that it would like its alternate proposed proprietary name reviewed.

  • Intended Pronunciation of the Proposed Proprietary Name-the applicant should provide a written transliteration of the intended pronunciation of the proposed proprietary name. “Although FDA evaluates the various pronunciations of a proposed name to reflect the variations that might be observed in clinical practice, consideration is given to the intended pronunciation of the name that the applicant or sponsor will promote, as this may influence pronunciation of the name in practice.”

  • Derivation of Proprietary Name-an explanation of the derivation of the proposed proprietary name, if any.

  • Intended Meaning of Proprietary Name Modifiers (e.g., prefix, suffix)-because a prefix or suffix might suggest different meanings to healthcare professionals and consumers, product confusion could result. “The submission should include the intended meaning of the modifier, the rationale for the modifier, and any studies that have been conducted to support the use of the modifier.”

  • Pharmacologic/Therapeutic Category-a pharmacologic/therapeutic category under which the product will be classified.

The guidance also details what labeling information and what dispensing and delivery information should be included. If a product does not have proposed labeling at the time of submission, the applicant should provide FDA with information on the product’s established name, prescription status, dosage form, product strength, proposed indications for use, route of administration, dosage information, instructions for use, storage requirements, and packaging configuration.

Source: FDA