Draft Guidance Details Complete Proprietary Names Package

Rockville, MD (Nov. 26)-The US Food and Drug Administration issued a draft guidance, Contents of a Complete Submission for the Evaluation of Proprietary Names, on Nov. 24, 2008. FDA uses information from these submissions to assess the safety aspects of a proposed proprietary name in an effort to reduce medication errors as well as to ensure compliance with labeling and promotion requirements.

The Prescription Drug User Fee Act of 2007 (PDFUA IV) calls for FDA to use user fees to “reduce medication errors related to look-alike and sound-alike proprietary names, unclear label abbreviations, acronyms, dose designations, and error-prone label and packaging designs,” according to the draft guidance.

Under the draft guidance, an FDA evaluation of a proprietary name review package will not begin until the submission is complete. A complete package will include the drug sponsor’s: proposed first choice proprietary name; application number; contact information; identification of the type of submission; and a list of contents in the submission such as labeling information, dosage form, route of administration, and so forth.

The draft guidance applies to both nonprescription and prescription drug products, including biologics, that are the subject of a new drug application, abbreviated new drug application, biologics license application, or investigational new drug application.

The full guidance is available here.

Comments on the draft guidance are due within 60 days to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.