JUL 29, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Mycophenolic Acid (REMS)
U.S. Food and Drug Administration
FDA supplemental approval for REMS (Risk Evaluation and Mitigation Strategy) on mycophenolic acid formulations; this is a regulatory action, not a clinical efficacy study.
Reported
Approval status date2026-07-29
ANDA number208315