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This document notifies the withdrawal of FDA approval for the familial adenomatous polyposis indication for CELEBREX, as requested by Pfizer, Inc.
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How to fill out notice of withdrawal of
How to fill out Notice of Withdrawal of Approval for Familial Adenomatous Polyposis Indication for CELEBREX
01
Obtain the Notice of Withdrawal of Approval form from the appropriate regulatory agency or online.
02
Fill in the patient's name and identification details at the top of the form.
03
Specify 'Familial Adenomatous Polyposis' as the indication for CELEBREX in the designated section.
04
Provide the date of the withdrawal request.
05
Include relevant medical history and reasons for the withdrawal in the appropriate section.
06
Sign and date the form at the bottom to confirm the submission.
07
Submit the completed form to the designated authority, ensuring to keep a copy for personal records.
Who needs Notice of Withdrawal of Approval for Familial Adenomatous Polyposis Indication for CELEBREX?
01
Healthcare providers managing patients with Familial Adenomatous Polyposis.
02
Pharmaceutical companies that marketed CELEBREX for this indication.
03
Regulatory bodies overseeing drug approvals and indications.
04
Patients who are affected by the withdrawal of this indication and may need to understand the implications.
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People Also Ask about
Why did Celebrex get taken off the market?
Amid concerns about reports of severe cutaneous reactions (Stevens–Johnson syndrome, erythema multiforme, toxic epidermal necrolysis) among patients taking valdecoxib,3 the drug was removed from the market.
Why was Celebrex banned?
CELEBREX is available by prescription only. Patients should always ask their doctors for medical advice about adverse events.
Is Celebrex still being sold?
Celecoxib, like the non-specific NSAIDs, can adversely affect kidney function. For this reason, people with abnormal kidney function should avoid or sharply limit the use of this medication, and if it is used the kidney function should be followed.
Do doctors still prescribe Celebrex?
Brand names. Pfizer markets celecoxib under the brand name Celebrex, and it is available as oral capsules containing 50, 100, 200, or 400 mg of celecoxib. It is legally available in many jurisdictions as a generic under several brand names.
What medication is used for familial adenomatous polyposis?
Drugs used in the treatment of FAP include sulindac and celecoxib. Note the following: Because of the association between cyclooxygenase 2 (COX-2) inhibitors (celecoxib is a member of this drug family) and coronary artery disease, celecoxib is no longer widely used.
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What is Notice of Withdrawal of Approval for Familial Adenomatous Polyposis Indication for CELEBREX?
The Notice of Withdrawal of Approval for Familial Adenomatous Polyposis Indication for CELEBREX is a formal notification indicating that the approval for the use of CELEBREX in treating familial adenomatous polyposis has been revoked, usually due to new safety data or lack of sufficient clinical evidence.
Who is required to file Notice of Withdrawal of Approval for Familial Adenomatous Polyposis Indication for CELEBREX?
The manufacturer or sponsor of CELEBREX is required to file the Notice of Withdrawal of Approval when they decide to withdraw the specific indication or when requested by regulatory authorities.
How to fill out Notice of Withdrawal of Approval for Familial Adenomatous Polyposis Indication for CELEBREX?
To fill out the Notice of Withdrawal, the sponsor must include details such as the drug's name, the specific indication being withdrawn, the reasons for withdrawal, any relevant regulatory references, and any supporting data or documentation justifying the decision.
What is the purpose of Notice of Withdrawal of Approval for Familial Adenomatous Polyposis Indication for CELEBREX?
The purpose of this notice is to formally communicate to regulatory authorities and the public that the approval for the use of CELEBREX in treating familial adenomatous polyposis is no longer valid, ensuring patient safety and upholding regulatory standards.
What information must be reported on Notice of Withdrawal of Approval for Familial Adenomatous Polyposis Indication for CELEBREX?
The report must contain information including the drug's identification, the specific indication being withdrawn, the effective date of the withdrawal, the reasons for withdrawal, and any relevant clinical evidence or studies that support the decision.
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