Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—NOTICES: Determination that rasuvo (methotrexate) solution was not withdrawn from sale for reasons of safety or effectiveness, (Jul 22, 2026)

By WK Editorial Staff

The determination will allow the FDA to approve ANDAs for rasuvo, if all other legal and regulatory requirements are met.

The FDA determined that rasuvo (methotrexate) solution, 27.5 milligrams (mg)/0.55 milliliter (mL) (27.5 mg/0.55 mL), was not withdrawn from sale for reasons of safety or effectiveness. initially approved on July 10, 2014. Rasuvo is a folate analog metabolic inhibitor indicated for the management of patients with severe, active rheumatoid arthritis and polyarticular juvenile idiopathic arthritis who are intolerant of or had an inadequate response to first-line therapy, and for symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy (Notice, 91 Fed. Reg. 46125 (July 22, 2026)).

Dates. July 21, 2026.

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