JUL 29, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Mycophenolate Sodium (REMS)
U.S. Food and Drug Administration
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing immunosuppressant; indicates regulatory action on safety management, not new clinical efficacy evidence.
Reported
Approval date2026-07-29
Formulation 1MYCOPHENOLATE SODIUM, TABLET, DELAYED RELEA…
Formulation 2MYCOPHENOLATE SODIUM, TABLET, DELAYED RELEA…