Search Results for citation:"90 FR 15243"

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Search Results: citation:"90 FR 15243"

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  • 2025-06050 — Determination That FLUMADINE (Rimantadine Hydrochloride) Tablet, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    Type:Notice
    Citation:90 FR 15243
    Reading Time:about 4 minutes

    The Food and Drug Administration (FDA) has determined that the drug FLUMADINE (rimantadine hydrochloride) 100 mg tablets were not taken off the market due to safety or effectiveness concerns. As a result, the FDA will not start withdrawing approval for generic versions of this drug, and it may continue approving them if they meet legal standards. FLUMADINE was originally approved in 1993 for treating and preventing influenza A in adults and for prevention in children. Despite being discontinued by the manufacturer, it remains listed in the Orange Book as discontinued for reasons other than safety or effectiveness.

    Simple Explanation

    The FDA says that the medicine FLUMADINE, which helps stop the flu, wasn't sold anymore, but not because it's unsafe or doesn't work. They will still let other companies make a similar medicine if they follow the rules.

  • 2025-06049 — Growing, Harvesting, Processing, and Distribution of Poppy Seeds-Industry Practices Related to Opiate Alkaloids; Request for Information; Extension of Comment Period
    Type:Notice
    Citation:90 FR 15243
    Reading Time:about 4 minutes

    The Food and Drug Administration (FDA) is extending the comment period for gathering information on industry practices related to poppy seeds. This includes cultivation, processing, and methods to reduce opiate alkaloid levels in poppy seeds. Due to requests for more time, the FDA is allowing an additional 60 days for comments, with submissions acceptable until June 16, 2025. This information will help the FDA decide if any actions are needed to ensure that poppy seed products are safe for consumption.

    Simple Explanation

    The FDA wants to learn more about how poppy seeds are grown and made into food so they can make them safer to eat. They are giving people more time to share what they know because it's an important topic.