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    • FOOD—U.S.: Supreme Court allows case involving alleged toxic baby food to advance
    • ADMINISTRATION OF FDC ACT—NOTICES: Determination that Tolectin DS (tolmetin sodium) capsule, equivalent to 400 milligrams base, not withdrawn from sale for reasons of safety or effectiveness
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    • FOOD—N.D. Ill.: Mother’s specific causation testimony survives in infant formula-induced NEC bellwether case
    • FOOD—NOTICES: Requirements for additional traceability records for certain foods; cottage cheese exemption
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    Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—NOTICES: Determination that Tolectin DS (tolmetin sodium) capsule, equivalent to 400 milligrams base, not withdrawn from sale for reasons of safety or effectiveness, (Feb 24, 2026)

    By WK Editorial Staff

    The FDA will continue to list Tolectin DS (tolmetin sodium) capsule, EQ 400 mg base, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book.

    The FDA determined that tolectin DS (tolmetin sodium) capsule, equiv ...

    By WK Editorial Staff

    The FDA will continue to list Tolectin DS (tolmetin sodium) capsule, EQ 400 mg base, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book.

    The FDA determined that tolectin DS (tolmetin sodium) capsule, equivalent to 400 milligrams (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. Tolectin DS is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolectin DS is indicated in the treatment of acute flares and the long-term management of the chronic disease and also indicated for treatment of juvenile rheumatoid arthritis. The determination will allow the FDA to approve abbreviated new drug applications (ANDAs) for tolmetin sodium, capsule, EQ 400 mg base, if all other legal and regulatory requirements are met (Notice, 91 Fed. Reg. 7500 (Feb. 18, 2026)).

    Dates. February 17, 2026.

    FederalRegisterIssuances: Notices FDCActNews PrescriptionDrugNews SafetyNews

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