Overview
Title
Determination That Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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ELI5 AI
The FDA says that some medicines, like Bentyl, are safe to use and weren't stopped because they're unsafe. This means stores can still sell similar medicines if they follow the rules.
Summary AI
The Food and Drug Administration (FDA) announced that certain drug products, including Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, have not been taken off the market for safety or effectiveness issues. This means that generic versions of these drugs can still be approved by the FDA and sold, as long as they follow the necessary legal and regulatory guidelines. The drugs will be listed in the "Discontinued Drug Product List" in the Orange Book because they are no longer being sold, but not for reasons related to safety or effectiveness.
Abstract
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
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AnalysisAI
Summary of the Document
The document is a notice from the Food and Drug Administration (FDA) stating that certain drug products, including Bentyl Preservative Free (Dicyclomine Hydrochloride), have not been withdrawn from the market for reasons of safety or effectiveness. The FDA ensures that these drugs can still be commercially available as generics, provided they meet legal and regulatory criteria. Although these drugs are no longer being marketed, they will be noted in the "Discontinued Drug Product List" in the FDA's Orange Book not due to safety concerns but simply because they are not currently sold.
Significant Issues or Concerns
One major concern with the document is its technical nature, which could make it challenging for individuals without a background in pharmaceuticals or regulatory law to understand. The document references complex legal sections, such as specific clauses from the Federal Food, Drug, and Cosmetic Act and the Code of Federal Regulations, which may not be easily interpreted by a general audience. Furthermore, the document presupposes familiarity with industry-specific terms and resources like ANDAs (Abbreviated New Drug Applications), NDAs (New Drug Applications), and the Orange Book, potentially alienating those outside the field.
Additionally, while the document states that the drugs were not withdrawn for safety reasons, it lacks detailed information about the specific products assessed beyond naming Bentyl. This omission might leave readers wanting more clarity on which other drugs are involved.
Impact on the Public Broadly
For the general public, this notice provides reassurance that certain medications are not being removed due to health or safety concerns. This means patients relying on these medications for treatment can continue doing so without worrying about potential safety issues. However, the complexity of the document might mean that the average individual does not fully understand the implications unless they have additional context or explanation.
Impact on Specific Stakeholders
For pharmaceutical manufacturers and companies seeking to produce generic drugs, this notice clarifies that they can continue to seek approval for generics of the listed drugs, as long as they adhere to the necessary standards. This continuity is advantageous as it allows companies to keep their products on the market without needing to redo extensive testing.
Conversely, the lack of detail regarding specific products might be frustrating for those directly affected or involved in the production or distribution of these medications, as it leaves critical questions unanswered.
The document also touches on potential label changes, which could impact how manufacturers present these medications. However, it does not specify how FDA guidance on such changes will be communicated, which could lead to uncertainty for those needing to comply with updated labeling requirements.
Overall, while the document's findings are positive, its dense technical language and lack of detailed product information might limit its effectiveness in communicating its messages to a broader audience.
Issues
• The document contains technical regulatory references which may be difficult for a general audience to fully understand, such as citations to specific sections of the Federal Food, Drug, and Cosmetic Act (e.g., Section 505(j)) and Code of Federal Regulations (21 CFR).
• The language used to describe the process and criteria for determining whether drugs were withdrawn for safety or effectiveness reasons can be complex (e.g., the explanation of § 314.161(a) and its implications).
• There is a lack of specific details about the drug products being referenced (aside from Bentyl Preservative Free), which may not fully inform the reader about which products were assessed.
• The document assumes prior knowledge of what terms like ANDAs, NDAs, and the Orange Book are, which might not be common knowledge outside of regulatory or pharmaceutical fields.
• The contact information provided is specific and helpful, but might not offer alternate methods of communication for individuals who prefer not to use email or telephone.
• The notice does not specify how the FDA intends to advise ANDA applicants about necessary labeling changes, which could be relevant for manufacturers.