Search Results for keywords:"drug approval withdrawal"

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Search Results: keywords:"drug approval withdrawal"

  • 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.

  • Type:Notice
    Citation:89 FR 107146
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) is withdrawing approval for two abbreviated new drug applications (ANDAs) from Flamingo Pharmaceuticals Ltd. This decision is because the company has consistently failed to submit the necessary annual reports for these drug applications. Despite being given a chance for a hearing, the company did not respond, resulting in a waiver of their hearing opportunity and any claims about the drug's legal status. Therefore, the approval for these drugs will officially be withdrawn on December 31, 2024.

    Simple Explanation

    The FDA, which makes sure medicines are safe, decided to stop letting Flamingo Pharmaceuticals sell two of their medicines because the company didn't send in their homework about the medicines on time.

  • Type:Notice
    Citation:90 FR 15247
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) is withdrawing approval for 18 new drug applications because the companies that made them have told the FDA that they are no longer selling these drugs. The companies also asked the FDA to withdraw their drug approvals and agreed not to have a hearing about it. This means that starting from May 9, 2025, selling these drugs without approval would be against the law. However, any remaining stock of these drugs can still be sold until they are all gone, expire, or otherwise become non-compliant.

    Simple Explanation

    The FDA is taking away the approval for 18 medicines because the companies that made them said they don't want to sell these medicines anymore and asked for this to happen. Starting from May 9, 2025, these medicines can't be sold unless it's leftover stock that's still safe to use.

  • Type:Notice
    Citation:86 FR 4081
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) is withdrawing the approval of 27 abbreviated new drug applications because the companies that made these drugs told the FDA that they are no longer selling them. The withdrawal means these drugs will no longer have permission to be sold in the market. This action will take effect on February 16, 2021, but any remaining drug inventory that is still compliant with regulations can be used up until it runs out or expires.

    Simple Explanation

    The FDA is taking back its permission for 27 kinds of medicines because the companies who made them said they aren't selling them anymore, and starting February 16, 2021, these medicines can't be sold.