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This document discusses the FDA's evaluation of the proprietary name 'Surfaxin' for Lucinactant, focusing on safety and promotional aspects and potential medication errors related to name confusion.

How to fill out proprietary name review for

How to fill out Proprietary Name Review for Surfaxin

1. Gather all necessary information about Surfaxin, including its intended use and target demographic.
2. Review existing proprietary names in the market to avoid similarities and ensure uniqueness.
3. Complete the proprietary name submission form provided by the regulatory authority.
4. Provide a rationale for the selected name, highlighting its relevance to the product and its intended use.
5. Submit the form along with any required documents or supporting data to the appropriate regulatory body.
6. Monitor the submission status and be prepared to respond to any inquiries or requests for clarification.

Who needs Proprietary Name Review for Surfaxin?

1. Pharmaceutical companies developing or planning to market Surfaxin.
2. Regulatory affairs professionals involved in the registration of Surfaxin.
3. Product branding teams seeking to ensure the proprietary name is compliant with regulations.

People Also Ask about

Is the generic name the proprietary name?

All generic drugs have a brand name as well as a non-proprietary name but all drugs having a non-proprietary name (generic name) may not be generic drugs.

What is the brand name for surfaxin?

Surfaxin (lucinactant) dosing, indications, interactions, adverse effects, and more.

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Loxapine, sold under the brand names Loxitane and Adasuve (inhalation only) among others, is a tricyclic antipsychotic medication used primarily in the treatment of schizophrenia.

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Mesalamine DR (Lialda) is an aminosalicylate that's used to treat mild-to-moderate ulcerative colitis (UC) in adults and children. It's a delayed-release (DR) tablet that's taken by mouth once daily with food.

What is the brand name for novolin?

Humulin N and Novolin N are both brand names for the same drug, called insulin NPH. Insulin NPH is an intermediate-acting insulin.

For pdfFiller’s FAQs

What is Proprietary Name Review for Surfaxin?

Proprietary Name Review for Surfaxin is a process conducted by regulatory authorities to evaluate the proposed proprietary name of Surfaxin, ensuring it is not misleading and does not create confusion with existing drug names.

Who is required to file Proprietary Name Review for Surfaxin?

The manufacturer or sponsor of Surfaxin is responsible for filing the Proprietary Name Review as part of the drug approval process with the regulatory agency.

How to fill out Proprietary Name Review for Surfaxin?

To fill out the Proprietary Name Review for Surfaxin, the sponsor must provide relevant details such as the proposed name, the rationale behind the choice, and any studies or data supporting the name's safety and distinctiveness.

What is the purpose of Proprietary Name Review for Surfaxin?

The purpose of the Proprietary Name Review for Surfaxin is to safeguard public health by preventing medication errors and ensuring that the drug's name is not easily confused with other products.

What information must be reported on Proprietary Name Review for Surfaxin?

The information reported on the Proprietary Name Review for Surfaxin includes the proposed name, alternatives considered, the significance of the name, potential for confusion with other drugs, and clinical safety data supporting the name.