Overview
Title
Determination That ETHYOL (Amifostine) for Injection, 500 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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ELI5 AI
The FDA decided that a medicine called ETHYOL, which is used to protect the body during cancer treatment, was not taken off the shelves because it is unsafe or doesn't work. This means other companies can still make and sell generic versions of it.
Summary AI
The Food and Drug Administration (FDA) announced that ETHYOL (amifostine) for injection, 500 mg/vial, was not removed from the market due to safety or effectiveness issues. This ruling implies that the FDA will not take action to revoke approvals for generic versions of this drug and can continue approving such versions if they comply with legal standards. The determination follows a petition and a review of available data, with no evidence found suggesting safety problems. As such, ETHYOL will stay on the "Discontinued Drug Product List" for reasons unrelated to safety or effectiveness.
Abstract
The Food and Drug Administration (FDA, the Agency, or we) has determined that ETHYOL (amifostine) for injection, 500 milligrams (mg)/ vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
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AnalysisAI
General Summary
The document from the Food and Drug Administration (FDA) declares that the drug ETHYOL, used for specific cancer treatments, was not taken off the market due to any problems with safety or effectiveness. This means that generic versions of this drug can still be approved as long as they meet the necessary legal requirements. The FDA arrived at this decision after examining a citizen petition and reviewing existing data, concluding that there were no safety issues associated with the drug. Ethyol will remain on the list of discontinued drug products for reasons other than safety or effectiveness.
Significant Issues or Concerns
The document uses technical language, which assumes that readers have some knowledge of FDA procedures and terminology. This might make it difficult for the general public to fully understand the content. While the FDA clearly states that Ethyol was not withdrawn due to safety concerns, it does not explain the actual reasons for its discontinuation, which may leave readers wanting more information. Furthermore, it mentions possible revisions to the drug’s labeling without detailing what changes would be necessary, leading to possible confusion among stakeholders.
Impact on the Public
This decision by the FDA could have implications for patients depending on generic versions of Ethyol for their treatment. The continued approval of generic versions means that patients will still have access to these potentially more affordable options for managing their health. This determination helps ensure that the market remains stable and that patients have continuous access to necessary medication.
Impact on Specific Stakeholders
For pharmaceutical companies, particularly those developing generic drugs, this ruling offers stability and clarity. Companies can move forward with or continue producing generic versions of Ethyol without the concern that approvals will be withdrawn, provided they comply with the legal and regulatory framework. For healthcare providers, this decision reassures them that the medications they prescribe are safe and effective, and they remain available on the market. Meanwhile, patients benefit from continued access to generic drugs, which may be more cost-effective than brand-name versions. However, the lack of disclosure about why Ethyol was discontinued might stir concerns among consumers seeking transparent information about the medications they use.
Issues
• The document is somewhat technical and assumes that readers have a level of familiarity with FDA processes and terminology, which may limit accessibility to general audiences.
• The document does not provide specific reasons why ETHYOL was discontinued, other than indicating it was not due to safety or effectiveness, which may leave some readers wanting more background information.
• The language used in the document may be considered overly formal or complex for readers who are not familiar with legal or regulatory jargon.
• The document briefly mentions that the product is listed as discontinued for reasons other than safety or effectiveness but does not elaborate on these reasons.
• The document states that if labeling should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling, but it does not specify what those revisions might entail.