Amneal

JUL 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Mycophenolate Mofetil (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for a Risk Evaluation and Mitigation Strategy (REMS) on an established generic medication; does not report clinical trial outcomes or efficacy data.

JUL 9, 2026 · REGULATORY APPROVAL

FDA approval: Sodium Bicarbonate (Type 5 - New Formulation or New Manufacturer)

U.S. Food and Drug Administration

FDA approval of a new formulation/manufacturer of sodium bicarbonate solution for intravenous use; this is a regulatory action, not a clinical efficacy study.

JUN 30, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Brimonidine Tartrate AND Timolol Maleate (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling of a fixed-dose combination ophthalmic agent; describes a regulatory action rather than clinical evidence of efficacy or safety.

MAY 14, 2026 · REGULATORY APPROVAL

FDA approval: Tretinoin

U.S. Food and Drug Administration

FDA approval of a generic topical tretinoin formulation; regulatory action, not clinical evidence of efficacy or safety.

MAY 12, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Pyridostigmine Bromide (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for pyridostigmine bromide labeling change; regulatory action without clinical trial data or efficacy claims.

APR 27, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Lenalidomide (REMS)

U.S. Food and Drug Administration

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