Overview
Title
Determination That RIOMET (Metformin Hydrochloride) Oral Solution, 500 Milligrams/5 Milliliters Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness
Agencies
ELI5 AI
The FDA says that a type of liquid medicine called RIOMET, which helps control blood sugar, was not taken off shelves because it was dangerous or didn't work. This means that other companies can make and sell this medicine too, as long as they follow the rules.
Summary AI
The Food and Drug Administration (FDA) confirmed that RIOMET, a metformin hydrochloride oral solution, was not taken off the market for safety or effectiveness issues. This finding means that the FDA can continue approving generic versions of this medication if they meet legal requirements. RIOMET is listed as discontinued in the FDA's "Orange Book," but this is not due to any safety concerns. As a result, companies can still seek approval to produce generic versions of RIOMET, provided they comply with all necessary regulations.
Abstract
The Food and Drug Administration (FDA or Agency) has determined that RIOMET (metformin hydrochloride) Oral Solution, 500 milligrams (mg)/5 milliliters (mL) has not been withdrawn from sale for reasons of safety or effectiveness.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
Summary of the Document
The document from the Federal Register provides an official notice from the Food and Drug Administration (FDA) regarding RIOMET (metformin hydrochloride) Oral Solution. It states that this medication, which had been discontinued from the market, was not removed due to safety or effectiveness issues. This finding permits the continued approval of generic versions by the FDA, provided they meet all necessary legal and regulatory conditions.
Significant Issues or Concerns
The document raises some issues that may need clarification. First, it references several legal sections from the Federal Food, Drug, and Cosmetic Act and the Code of Federal Regulations without explaining their implications. Such references might be obscure for readers not well-versed in pharmaceutical regulations.
Additionally, there are mentions of citizen petitions which instigated the FDA's review. The specific concerns or arguments these petitions raised are not detailed in the document, leading to some ambiguity about the underlying reasons for investigation.
The FDA claims to have reviewed relevant literature and postmarketing data for adverse events, yet the document lacks specific findings or data points to substantiate its conclusion that RIOMET was not withdrawn due to safety or effectiveness concerns.
Impact on the Public
The FDA's determination regarding RIOMET means that the public can expect some continuity in the availability of generic versions, which is often advantageous in maintaining choices and price competition in the pharmaceutical market. This notice might reassure consumers using metformin products for managing type 2 diabetes that the discontinuation of RIOMET was not due to harmful effects.
Impact on Stakeholders
Generic Drug Manufacturers: The FDA’s announcement is particularly significant for manufacturers of generic drugs. It indicates that they can continue or initiate production of generic versions of the RIOMET Oral Solution, expanding market opportunities as long as the products comply with existing regulations.
Patients and Healthcare Providers: Patients and healthcare providers concerned about the safety of metformin products might find this announcement reassuring. It supports ongoing confidence in this widely used diabetes medication, clarifying that the withdrawal was neither due to safety defects nor effectiveness shortcomings.
Regulatory and Advocacy Groups: Organizations focused on drug safety and advocacy may view this decision as indicative of FDA's diligence in reviewing and affirming the safety of medications available in the market. However, these groups may still seek more detailed information on the review process and conclusions.
In summarizing, while the document confirms continued support for generic versions of RIOMET, it leaves room for further inquiry into the specifics of the petitions and review methodologies used by FDA to establish its conclusions. Richer detail would enhance understanding for stakeholders interested in the procedural aspects of drug safety evaluations.
Issues
• The document summary provides clear information that RIOMET (metformin hydrochloride) Oral Solution has not been withdrawn for safety or effectiveness reasons, but it might be helpful to add a brief explanation or context about the significance of remaining on the 'Discontinued Drug Product List'.
• The document references multiple sections of the Federal Food, Drug, and Cosmetic Act and CFR (Code of Federal Regulations) without providing a brief explanation of their implications, which might be unclear to readers unfamiliar with these regulations.
• References to citizen petitions (Docket Nos. FDA-2023-P-0884 and FDA-2023-P-5687) are mentioned without elaborating on the specific concerns or arguments raised in these petitions, leaving some details potentially ambiguous.
• The document mentions that FDA has independently evaluated relevant literature and data for possible postmarketing adverse events but does not provide specific findings or data, leaving the basis for determination somewhat opaque.
• The text might be considered overly complex for readers who are not familiar with pharmaceutical regulatory language, such as terms like 'bioequivalent', 'abbreviated new drug applications (ANDAs)', and 'Orange Book'.
• Contact information is provided in a dense format, which could be difficult to parse quickly. Clearer formatting or a slightly different layout might improve readability.