Search Results for keywords:"ANDA"

Found 3 results

Search Results: keywords:"ANDA"

💰 Only
Oldest Newest
  • 2025-00742 — Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
    Type:Notice
    Citation:90 FR 3876
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) has decided to withdraw its approval of 23 abbreviated new drug applications (ANDAs) after being informed by the applicants that these drug products are no longer being marketed. This withdrawal is effective from February 14, 2025. The applicants have waived their right to a hearing regarding this decision. According to the regulations, any remaining inventory of these products can be dispensed until it runs out, expires, or otherwise becomes non-compliant.

    Simple Explanation

    The FDA is stopping the official approval of some medicines because the companies told them no one is selling these medicines anymore. They can still be used until they're gone or too old.

  • 2025-06050 — Determination That FLUMADINE (Rimantadine Hydrochloride) Tablet, 100 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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

  • 2025-04107 — Bausch & Lomb Incorporated, et al.; Withdrawal of Approval of Four Abbreviated New Drug Applications
    Type:Notice
    Citation:90 FR 12163
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) is withdrawing approval for four abbreviated new drug applications (ANDAs) because the manufacturers informed the FDA that these drugs are no longer being sold. The manufacturers requested this action and have given up their right to a hearing. As of April 14, 2025, these drugs cannot legally be sold or introduced into interstate commerce in the U.S. unless they have an approved application. However, any remaining stock of these drugs can be used until they expire or are sold out.

    Simple Explanation

    The FDA is taking away permission for some medicines because the companies said they don't sell them anymore. This means people can't legally sell these medicines in the U.S. unless they get new permission.