APR 13, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Lamotrigine (Labeling)
U.S. Food and Drug Administration
This is an FDA supplemental approval action for a labeling change to lamotrigine tablets; it documents a regulatory decision, not clinical trial evidence.
Reported
Approval date2026-04-13
SponsorALEMBIC PHARMS LTD
Submission typeSupplemental (labeling)