Macleods Pharms

AUG 11, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

This is an FDA supplemental approval action for metformin hydrochloride labeling; it documents a regulatory decision, not clinical trial evidence.

AUG 3, 2026 · REGULATORY APPROVAL

FDA approval: Nintedanib Esylate

U.S. Food and Drug Administration

FDA approval of a generic nintedanib esylate formulation; establishes bioequivalence and manufacturing compliance but does not report clinical efficacy or comparative trial data.

JUL 13, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Fenofibric Acid (Labeling)

U.S. Food and Drug Administration

This is an FDA supplemental approval action for labeling of fenofibric acid; it documents a regulatory decision, not clinical evidence of efficacy or safety.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Tramadol Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for tramadol hydrochloride extended-release tablets; this is a regulatory action, not a clinical efficacy study.

APR 7, 2026 · REGULATORY APPROVAL

FDA approval: Emtricitabine AND Tenofovir Alafenamide Fumarate

U.S. Food and Drug Administration

FDA approval of a generic fixed-dose combination antiretroviral tablet; confirms bioequivalence and manufacturing standards but does not report clinical trial efficacy data.

APR 6, 2026 · REGULATORY APPROVAL

FDA approval: Dapagliflozin AND Metformin Hydrochloride

U.S. Food and Drug Administration

FDA approval of a generic fixed-dose combination of dapagliflozin and metformin; this is a regulatory action record that does not report clinical trial data or comparative efficacy.