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Mycophenolate Mofetil · Regulatory label update
U.S. Food and Drug Administration · July 29, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA approved a supplemental REMS submission for mycophenolate mofetil 250 mg capsules (generic, Zhejiang Hisun Pharm) on 29 July 2026. This is a regulatory action related to risk management requirements and does not itself constitute evidence of clinical efficacy, safety, or comparative benefit; it reflects FDA's determination that a REMS strategy is necessary or modified for the product.
Regulatory label update.
Supplemental approval granted for REMS (Risk Evaluation and Mitigation Strategy) for mycophenolate mofetil 250 mg oral capsule
This record does not contain clinical trial results, efficacy data, or safety summaries. The basis for the REMS requirement (whether new safety signal or existing risk) is not specified in this document.
Clinicians should be aware that mycophenolate mofetil 250 mg capsules (Zhejiang Hisun Pharm) is subject to a REMS strategy; prescribers and patients must comply with all elements of that strategy. This regulatory action does not convey new clinical evidence about the drug's efficacy or adverse-event profile.
FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for an existing generic drug; this is a regulatory action, not clinical evidence of efficacy or safety.
Quoted from the source exactly as published.
Clinicians should be aware that mycophenolate mofetil 250 mg capsules (Zhejiang Hisun Pharm) is subject to a REMS strategy; prescribers and patients must comply with all elements of that strategy. This regulatory action does not convey new clinical evidence about the drug's efficacy or adverse-event profile.
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.
Drugs@FDA record for application ANDA204077. This is a regulatory action record, not a clinical study. Brand name: MYCOPHENOLATE MOFETIL. Active ingredient: MYCOPHENOLATE MOFETIL. Sponsor: ZHEJIANG HISUN PHARM. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-07-29. Products: MYCOPHENOLATE MOFETIL, CAPSULE, ORAL, MYCOPHENOLATE MOFETIL 250MG.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.