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This document serves as a consultation response from the Division of Medication Errors and Technical Support regarding the proprietary name 'Osmoprep' for a new drug application, assessing its potential

How to fill out proprietary name review consultation

How to fill out Proprietary Name Review Consultation Response

1. Gather all relevant information regarding the proprietary name.
2. Review the form instructions to ensure understanding of required information.
3. Provide the proposed proprietary name and any alternative names considered.
4. Justify the choice of the proprietary name with a brief description of its significance.
5. Include any relevant data on possible confusion with existing product names.
6. Review the entirety of the responses for completeness and accuracy before submission.

Who needs Proprietary Name Review Consultation Response?

1. Individuals or organizations developing new pharmaceutical products.
2. Regulatory affairs professionals involved in drug naming and marketing.
3. Companies seeking FDA approval for new proprietary names.

People Also Ask about

What does "proprietary" mean in drugs?

Definitions of proprietary drug. noun. a drug that has a trade name and is protected by a patent (can be produced and sold only by the company holding the patent) synonyms: brand-name drug. drug.

Which name is also referred to as the proprietary name?

Trade Name Also known as brand name or proprietary name. A drug sold by a drug company under a specific name or trademark and that is protected by a patent. Branded products are not generics. A brand can be first-in-class. It is protected by a patent or statutory exclusivity or has an expired patent or exclusivity.

What is an example of a proprietary name?

We also learn that cellophane and laundromat were once proprietary names (see 'anepronym', a trademarked name that has come to be used generically). These proprietary names are more memorable for a reason: each was developed at a cost of hundreds of thousands of pounds.

What is an example of a proprietary name?

For example, Kleenex, band aid, popsicle.

Which is another name for a proprietary drug name?

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).

What is a proprietary brand name?

A brand name or trademark belonging to the patent holder under which a medicine is marketed. Many medicines have one or more brand names. These are chosen by the company that makes them.

What is a proprietary name for FDA?

Trade Name Also known as brand name or proprietary name. A drug sold by a drug company under a specific name or trademark and that is protected by a patent. Branded products are not generics.

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What is Proprietary Name Review Consultation Response?

The Proprietary Name Review Consultation Response is a formal document submitted to the FDA that provides feedback on a proposed proprietary name for a drug, ensuring that it is not likely to cause confusion with existing drug names.

Who is required to file Proprietary Name Review Consultation Response?

Pharmaceutical companies and drug sponsors who are developing new drug applications or abbreviated new drug applications are required to file the Proprietary Name Review Consultation Response.

How to fill out Proprietary Name Review Consultation Response?

To fill out the Proprietary Name Review Consultation Response, a sponsor must provide the proposed name, a description of the product, rationale for the name choice, and any safety concerns related to name confusion.

What is the purpose of Proprietary Name Review Consultation Response?

The purpose of the Proprietary Name Review Consultation Response is to ensure that the proposed drug name is safe, effective, and not likely to be confused with other existing drug names, thus protecting patient safety.

What information must be reported on Proprietary Name Review Consultation Response?

The information that must be reported includes the proposed proprietary name, the active ingredient, dosage form, strength, route of administration, and any relevant labeling or marketing plans.