Search Results for keywords:"drug effectiveness"

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Search Results: keywords:"drug effectiveness"

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  • 2025-00357 — Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal
    Type:Notice
    Citation:90 FR 2008
    Reading Time:about 3 minutes

    The Food and Drug Administration (FDA) has renewed the charter for the Antimicrobial Drugs Advisory Committee until October 7, 2026. This independent advisory group helps the FDA ensure that drugs used to treat infectious diseases are safe and effective. The committee includes 13 voting members with expertise in fields like infectious diseases and internal medicine. The renewal is considered important to support public interest and ensure continued expert advice on drug safety and effectiveness.

    Simple Explanation

    The FDA is keeping a special group of experts, called the Antimicrobial Drugs Advisory Committee, to help make sure that medicines for infections are safe and work well, and this group will continue to do their job until 2026.

  • 2025-06050 — Determination That FLUMADINE (Rimantadine Hydrochloride) Tablet, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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.

  • 2021-00118 — Determination That ARALEN (Chloroquine Phosphate) Oral Tablets, 500 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    Type:Notice
    Citation:86 FR 1516
    Reading Time:about 2 minutes

    The Food and Drug Administration (FDA) announced that certain drug products, including ARALEN (Chloroquine Phosphate) oral tablets, were not removed from the market due to safety or effectiveness issues. This means that the FDA will continue to allow the approval of generic versions of these drugs through abbreviated new drug applications (ANDAs). The drugs will remain listed in the FDA's "Discontinued Drug Product List" in the Orange Book, indicating that their discontinuation was for reasons other than safety or effectiveness. If necessary, the FDA may request updates to the labels of these drugs to meet current standards.

    Simple Explanation

    The FDA says that some medicine, like ARALEN, is still safe and good to use, even though it's not sold anymore. They can still let others make the same medicine if they follow the rules.