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This document presents the final review of the proprietary name 'Omontys' for a drug application regarding safety and promotional assessments to avoid medication errors.

How to fill out proprietary name review--final

How to fill out Proprietary Name Review--Final

1. Gather necessary information about the drug or product.
2. Ensure you have the correct proprietary name and any alternative names.
3. Complete the application form with accurate details.
4. Provide rationale for the chosen proprietary name.
5. Submit any supporting documents required for the review.
6. Review the submission for completeness before sending it to the appropriate agency.
7. Wait for feedback or approval from the reviewing body.

Who needs Proprietary Name Review--Final?

1. Pharmaceutical companies seeking approval for new drug names.
2. Developers of medical products requiring distinct identities.
3. Regulatory professionals involved in the drug approval process.

People Also Ask about

What is an example of a proprietary name?

For example, Kleenex, band aid, popsicle.

What is a proprietary name for FDA?

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 does proprietary brand name mean?

a name of a product or service that is protected by a patent, copyright, or trademark and cannot be used by another party for commercial purposes without permission of the registered owner or licensee.

What is a drug's proprietary name?

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.

What is the difference between proprietary name and brand name?

Non-proprietary name is the name for the active ingredient in the medicine that is decided by an expert committee and is understood internationally (WHO, 2013a). Thus, paracetamol/acetaminophen is the non-proprietary name (generic name) while Crocin/Metacin/Meftal/Tylenol etc. are brand names.

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 the trade or proprietary name of a drug?

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.

Is proprietary name the same as brand name?

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).

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What is Proprietary Name Review--Final?

Proprietary Name Review--Final is a process conducted by regulatory agencies to evaluate and approve the final proprietary name of a drug to ensure it is not misleading and is distinct from other drugs.

Who is required to file Proprietary Name Review--Final?

Any pharmaceutical company seeking approval for a new drug or a new proprietary name for an existing drug is required to file Proprietary Name Review--Final with the relevant regulatory authority.

How to fill out Proprietary Name Review--Final?

To fill out Proprietary Name Review--Final, applicants must complete the designated forms with accurate drug name information, provide rationale for the chosen name, and include any relevant supporting documentation as outlined by the regulatory agency.

What is the purpose of Proprietary Name Review--Final?

The purpose of Proprietary Name Review--Final is to ensure that the proposed drug name is not only legally acceptable but also does not cause confusion with existing drug names, which could potentially lead to medication errors.

What information must be reported on Proprietary Name Review--Final?

The information that must be reported includes the proposed proprietary name, details about the drug, a summary of the name selection process, potential risks associated with the name, and any research supporting the name's distinctiveness.