Search Results for keywords:"new animal drug applications"

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Search Results: keywords:"new animal drug applications"

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  • 2021-03250 — New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
    Type:Rule
    Citation:86 FR 10819
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) is withdrawing approval of seven new animal drug applications because the companies responsible for these drugs repeatedly failed to submit the required annual reports. The FDA had previously offered these companies the chance for a hearing, but they did not respond, which meant they gave up that opportunity and any arguments about the legal status of the drugs. As a result, these drug approvals will no longer be valid starting February 23, 2021.

    Simple Explanation

    The FDA has decided to stop allowing seven types of medicines for animals to be sold because the companies making them didn't do their homework and send important reports on time.

  • 2024-28061 — New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
    Type:Rule
    Citation:89 FR 95101
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) has made changes to rules about animal drugs to update new and existing drug applications, improve readability, and ensure accurate information. These updates reflect approvals, withdrawals, and sponsorship changes for animal drugs from July to September 2024. The FDA also amended its regulations to communicate these changes and to clarify the information about sponsors and conditions of use for drugs. This rule is effective as of December 2, 2024.

    Simple Explanation

    The FDA updated the rules about animal medicines to make sure everything is clear and correct, like giving new permissions or changing who is in charge of the medicines.

  • 2025-01226 — New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
    Type:Rule
    Citation:90 FR 6797
    Reading Time:about 16 minutes

    The Food and Drug Administration (FDA) is updating animal drug regulations to reflect actions related to new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) from October to December 2024. Some approvals for specific animal drugs have been withdrawn because they are no longer manufactured or marketed. Additionally, the FDA is making technical amendments to enhance the accuracy and clarity of the regulations, updating sponsor information, and making adjustments in drug sponsorships and addresses. These changes take effect on January 21, 2025.

    Simple Explanation

    The FDA is making changes to how they keep track of animal medicines, updating the rules, and changing some company names and addresses. These changes are like cleaning up to make sure everything is neat, clear, and makes sense, starting on January 21, 2025.

  • 2021-03251 — New Animal Drug Applications; Beta-Aminopropionitrile Fumarate; n-Butyl Chloride; Cupric Glycinate Injection; Dichlorophene and Toluene; Orgotein for Injection; Tetracycline Tablets
    Type:Rule
    Citation:86 FR 10818
    Reading Time:about 4 minutes

    The Food and Drug Administration (FDA) has updated regulations to reflect the withdrawal of approval for seven new animal drug applications due to non-compliance with reporting requirements. This change means that certain firms are no longer recognized as sponsors for these drugs. The decision takes effect on February 23, 2021, and involves technical amendments to various parts of the Code of Federal Regulations to ensure accuracy. The rule does not impose any new burdens on businesses and is not subject to further review or certain regulatory requirements.

    Simple Explanation

    The FDA took away permission for some medicines made for animals because the companies didn’t follow all the rules about telling the FDA how the medicines were working. This means the medicines might not be available from those companies anymore.