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This document is a review conducted by the FDA's Division of Medication Error Prevention and Analysis focusing on the proprietary name, Lamictal ODT, assessing risks of confusion and medication errors
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How to fill out proprietary name review for
How to fill out Proprietary Name Review for Lamictal ODT
01
Gather necessary product information, including the active ingredient (Lamotrigine) and dosage form (ODT).
02
Navigate to the Proprietary Name Review submission portal.
03
Complete the initial form with basic product details.
04
Provide a proposed proprietary name for the product, ensuring it complies with FDA guidelines.
05
Include a rationale for the proposed name, explaining its significance and relevance.
06
Submit any required supporting documents, such as labeling and packaging mock-ups.
07
Review the submission for accuracy and completeness before final submission.
Who needs Proprietary Name Review for Lamictal ODT?
01
Manufacturers developing Lamictal ODT.
02
Pharmaceutical companies seeking to market the drug.
03
Regulatory professionals ensuring compliance with FDA standards.
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People Also Ask about
What is the original brand of lamotrigine?
Lamotrigine is sold under the original brand name Lamictal and it is available in generic form under many brand names worldwide.
What is the most concerning side effect of lamotrigine?
Lamotrigine may cause serious allergic reactions affecting multiple body organs (eg, liver or kidney). Check with your doctor right away if you or your child have the following symptoms: fever, dark , headache, hives, muscle pain or stiffness, stomach pain, unusual tiredness, or yellow eyes or skin.
Is there a difference between Lamictal generic and name brand?
The study found the generic was bioequivalent to Lamictal and had similar within-patient variability, providing strong evidence that the two drugs could be used interchangeably. No significant differences in control of epileptic seizures were observed.
What is lamotrigine's brand name?
Lamotrigine is a medication that treats epilepsy by preventing and controlling seizures. It can also treat bipolar disorder. It works by calming overactive nerves in your body. Common brand names of this medication are Lamictal® and Subvenite®.
What is the most serious side effect of lamotrigine?
Lamotrigine may cause serious allergic reactions affecting multiple body organs (eg, liver or kidney). Check with your doctor right away if you or your child have the following symptoms: fever, dark , headache, hives, muscle pain or stiffness, stomach pain, unusual tiredness, or yellow eyes or skin.
What is the proprietary name for lamotrigine?
Common brand names of this medication are Lamictal® and Subvenite®.
What is the brand name of lamotrigine tablets?
Brand name: Lamictal. Find out how lamotrigine treats epilepsy and bipolar disorder, and how to take it.
Is Lamictal a good seizure medication?
Lamotrigine is a medicine used to treat epilepsy. It can also help prevent low mood (depression) in adults with bipolar disorder. Seizures are bursts of electrical activity in the brain that temporarily affect how it works. Lamotrigine slows these electrical signals down to stop seizures.
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What is Proprietary Name Review for Lamictal ODT?
Proprietary Name Review for Lamictal ODT is a process conducted by regulatory authorities to evaluate the proposed brand name for the medication, ensuring it is not misleading, confusingly similar to existing names, or suggesting efficacy or safety.
Who is required to file Proprietary Name Review for Lamictal ODT?
The manufacturer or sponsor of Lamictal ODT is required to file the Proprietary Name Review as part of their regulatory submission for marketing approval.
How to fill out Proprietary Name Review for Lamictal ODT?
To fill out the Proprietary Name Review for Lamictal ODT, the applicant must provide detailed information about the proposed name, including its intended use, a rationale for the selection, and any supporting data to demonstrate its uniqueness and appropriateness.
What is the purpose of Proprietary Name Review for Lamictal ODT?
The purpose of Proprietary Name Review for Lamictal ODT is to ensure that the name is safe for public use, does not lead to medication errors, and is easily identifiable by healthcare providers and patients.
What information must be reported on Proprietary Name Review for Lamictal ODT?
Information that must be reported includes the proposed proprietary name, reasons for selection, analysis of potential confusion with other names, and any consumer testing results that support the name's clarity and appeal.
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