Sandoz

AUG 13, 2026 · REGULATORY APPROVAL

FDA approval: Fidaxomicin

U.S. Food and Drug Administration

FDA approval of a generic fidaxomicin formulation; regulatory action does not itself establish clinical efficacy or comparative benefit.

AUG 12, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Difluprednate Ophthalmic (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling change to difluprednate ophthalmic; does not report clinical trial outcomes or comparative efficacy data.

AUG 11, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for metformin hydrochloride labeling change; records a regulatory action, not clinical trial evidence.

JUL 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Mycophenolate Mofetil (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate mofetil; this is a regulatory action, not a clinical trial, and does not report efficacy or comparative clinical outcomes.

JUL 23, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Tyruko (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for a REMS (Risk Evaluation and Mitigation Strategy) regulatory requirement; does not contain clinical trial data or efficacy evidence.

JUN 3, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Argatroban IN Dextrose (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling for an existing argatroban formulation; does not contain clinical trial data or efficacy evidence.

MAY 12, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Ziextenzo (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling change to pegfilgrastim-bmez (Ziextenzo); regulatory action without clinical trial data.

MAY 6, 2026 · REGULATORY APPROVAL

FDA approval: Vasopressin

U.S. Food and Drug Administration

FDA approval of a generic vasopressin formulation; regulatory milestone with no clinical trial data in this record.