Search Results for keywords:"abbreviated new drug applications (ANDAs)"

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Search Results: keywords:"abbreviated new drug applications (ANDAs)"

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  • 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— Determination That ARALEN (Chloroquine Phosphate) Oral Tablets, 500 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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.

  • 2025-06053 — Determination That VIBRAMYCIN (Doxycycline) for Oral Suspension, Equivalent 25 Milligrams Base/5 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
    Type:Notice
    Citation:90 FR 15253
    Reading Time:about 3 minutes

    The Food and Drug Administration (FDA) has determined that the drug VIBRAMYCIN (doxycycline) for oral suspension was not taken off the market due to safety or effectiveness concerns. This decision allows the FDA to continue approving generic versions of this medication as long as they meet legal and regulatory criteria. VIBRAMYCIN is included in the “Discontinued Drug Product List” because it was removed from sale for reasons unrelated to safety or effectiveness. If necessary, the FDA may require updates to the drug’s labeling to align with current standards.

    Simple Explanation

    The FDA is like a big safety team for medicines, and they checked a medicine called VIBRAMYCIN to make sure it's still okay to use. They found that it wasn't taken away because it was unsafe or didn't work, so they are letting other companies make similar versions, as long as they follow the rules.

  • 2024-28433 — 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
    Type:Notice
    Citation:89 FR 96654
    Reading Time:about 2 minutes

    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.

    Simple Explanation

    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.

  • 2025-04020 — Determination That RIOMET (Metformin Hydrochloride) Oral Solution, 500 Milligrams/5 Milliliters Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness
    Type:Notice
    Citation:90 FR 11991
    Reading Time:about 3 minutes

    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.

    Simple Explanation

    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.