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This document outlines the evaluation of the proprietary name 'Creon Minimicrospheres' for a pancreatic enzyme product, providing recommendations to avoid potential medication errors related to name
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How to fill out PROPRIETARY NAME REVIEW(S) CONSULTATION RESPONSE

01
Begin by reviewing the guidelines provided for the Proprietary Name Review.
02
Gather all necessary information about the product, including its intended use and target population.
03
Fill in the basic information section with the proprietary name, sponsor name, and other relevant details.
04
Complete the safety and efficacy data section, providing evidence to support the name's appropriateness.
05
Address any potential confusion with existing products by comparing the proprietary name to other names in the market.
06
Submit any additional documentation required, like labeling and marketing materials.
07
Review your response for completeness and accuracy before submission.
08
Submit the Proprietary Name Review Consultation Response through the designated electronic submission portal.

Who needs PROPRIETARY NAME REVIEW(S) CONSULTATION RESPONSE?

01
Pharmaceutical companies seeking approval for new drug names.
02
Manufacturers of medical devices requiring proprietary name review.
03
Regulatory professionals working on product branding.
04
Marketing teams involved in the naming of healthcare products.
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WHAT IS A PROPRIETARY NAME? The proprietary name is the exclusive name the sponsor or distributor assigns to a drug product (see Guidance for Industry (GFI) #240). It is commonly known as the brand name or trade name and may include trademarked and non-trademarked words (or numbers).
WHAT IS A PROPRIETARY NAME? The proprietary name is the exclusive name the sponsor or distributor assigns to a drug product (see Guidance for Industry (GFI) #240). It is commonly known as the brand name or trade name and may include trademarked and non-trademarked words (or numbers).
For example, Kleenex, band aid, popsicle.
Broadly defined as drugs that are marketed under trade names and have patents, which can be a synonym of proprietary drugs in daily use. Strictly speaking, every drug with a trade name is a brand name drug, such as Panadol, a GSK branded paracetamol.
Some examples of private label brands are Up and Up from Target, Great Value from Walmart, Insignia branded electronics from Best Buy and Trader Joes brand. Private labels are only available at the specific retailer they were produced for.
The "proprietary name" or "trade name" of a product is the name that will: be used by the applicant or other entity for the commercial distribution of the product; identify the specific product in the marketplace, following approval by the Center for Biologics Evaluation and Research (CBER).
proprietary name in British English noun. a name that is a trademark.
Brand name of drugs and devices Proprietary names are the names that have been assigned to products, usually drugs and devices, by their corporate producers. They do not require a license from the producer. It is both necessary and useful to include proprietary names in a health terminology.

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The PROPRIETARY NAME REVIEW(S) CONSULTATION RESPONSE is a document that provides feedback or a decision regarding the proposed proprietary name of a drug or product, ensuring it meets regulatory standards and does not cause confusion with existing products.
Manufacturers or sponsors of drug products that are seeking approval for a proprietary name are required to file a PROPRIETARY NAME REVIEW(S) CONSULTATION RESPONSE to ensure their chosen name is acceptable.
To fill out a PROPRIETARY NAME REVIEW(S) CONSULTATION RESPONSE, the applicant must provide detailed information about the proposed name, including its design, reasons for selection, and any relevant supportive data regarding its uniqueness and safety.
The purpose of the PROPRIETARY NAME REVIEW(S) CONSULTATION RESPONSE is to evaluate the potential for name confusion, assess the appropriateness of the proposed name, and ensure it aligns with regulatory guidelines, ultimately enhancing patient safety.
The information that must be reported on the PROPRIETARY NAME REVIEW(S) CONSULTATION RESPONSE includes the proposed proprietary name, the drug's active ingredients, its formulation, intended use, and any comparative analysis with existing names that highlight its distinctiveness.
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Relevant keywords

FDA Creon proprietary name review pancreatic enzyme medication errors pharmaceutical consultation response drug safety

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