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Methotrexate · Regulatory label update
U.S. Food and Drug Administration · May 27, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA supplemental approval action for a labeling change to Jylamvo (methotrexate 2 mg/mL oral solution) by Shorla, approved 27 May 2026. The record documents the regulatory action only and does not contain clinical trial results, efficacy data, or safety findings.
Regulatory label update.
This is an FDA supplemental approval action for a labeling change to Jylamvo (methotrexate 2 mg/mL oral solution) by Shorla, approved 27 May 2026. The record documents the regulatory action only and does not contain clinical trial results, efficacy data, or safety findings.
No safety or efficacy outcomes reported.
The source did not state who this applies to in practice.
FDA supplemental approval for methotrexate oral solution labeling change; regulatory action only, no clinical trial data presented.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings, reported figures. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application NDA212479. This is a regulatory action record, not a clinical study. Brand name: JYLAMVO. Active ingredient: METHOTREXATE. Sponsor: SHORLA. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-27. Products: JYLAMVO, SOLUTION, ORAL, METHOTREXATE 2MG/ML; JYLAMVO, SOLUTION, ORAL, METHOTREXATE 2MG/ML; JYLAMVO, SOLUTION, ORAL, METHOTREXATE 2MG/ML; JYLAMVO, SOLUTION, ORAL, METHOTREXATE 2MG/ML.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.