Mylan

AUG 11, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for an established generic metformin hydrochloride formulation; regulatory action without new clinical trial data.

JUL 28, 2026 · REGULATORY APPROVAL

FDA approval: Sugammadex

U.S. Food and Drug Administration

FDA approval of a generic sugammadex formulation; regulatory action does not provide clinical trial evidence of efficacy or comparative benefit.

JUN 25, 2026 · REGULATORY APPROVAL

FDA approval: Ferric Carboxymaltose

U.S. Food and Drug Administration

FDA approval of a generic ferric carboxymaltose formulation; regulatory action confirming bioequivalence or abbreviated pathway clearance, not a clinical efficacy trial.

JUN 25, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Amlodipine AND Atorvastatin (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling for a fixed-dose combination of amlodipine and atorvastatin; this is a regulatory action, not a clinical evidence report, and does not contain trial outcomes or efficacy data.