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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:
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.