JUL 29, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Mycophenolate Mofetil Hydrochloride (REMS)
U.S. Food and Drug Administration
FDA supplemental approval of mycophenolate mofetil hydrochloride injectable formulation under REMS requirements; regulatory action without clinical trial outcome data.
Reported
Approval status date2026-07-29
Product strength500 mg/vial