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    • TOBACCO—Ala. Sup. Ct.: Preliminary injunction denied where challenge to ENDS Act failed to demonstrate likelihood of success
    • DRUGS AND BIOLOGICS—NOTICES: FDA withdraws approval for multiple NDAs
    • ELECTRONIC HEALTH RECORDS—M.D. Fla.: Suit against physical therapy clinic franchisor over data breach can proceed
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    • PRESCRIPTION DRUGS—8th Cir.: Denial of preliminary relief affirmed in Novartis challenge to Missouri 340B drug delivery law
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    Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—NOTICES: FDA withdraws approval for multiple NDAs, (Jul 9, 2026)

    By WK Editorial Staff

    The FDA is withdrawing approval of 34 new drug applications (NDAs) from multiple applicants.

    The applicants notified the FDA in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. Ap ...

    By WK Editorial Staff

    The FDA is withdrawing approval of 34 new drug applications (NDAs) from multiple applicants.

    The applicants notified the FDA in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. Approval of each entire application is withdrawn, including any strengths and dosage forms included in the application (Notice, 91 Fed. Reg. 41045 (July 6, 2026)).

    Dates. Approval is withdrawn as of August 5, 2026.

    FederalRegisterIssuances: Notices FDCActNews DrugBiologicNews

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