Aurobindo Pharma

AUG 11, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Clindamycin Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling for an existing generic drug; no clinical efficacy or safety data presented.

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 metformin hydrochloride extended-release tablets; this is a regulatory action record, not a clinical trial, and does not contain efficacy or safety data.

JUL 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Mycophenolate Mofetil (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for REMS modification; does not report clinical trial outcomes or efficacy data.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Tramadol Hydrochloride AND Acetaminophen (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a fixed-dose tramadol–acetaminophen combination tablet with REMS requirements; this is a regulatory action, not a clinical efficacy study.

JUN 10, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Acetaminophen AND Ibuprofen Back Pain (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling of a fixed-dose combination product; does not contain clinical trial data or efficacy evidence.

JUN 9, 2026 · REGULATORY APPROVAL

FDA approval: Cephalexin

U.S. Food and Drug Administration

FDA approval of a generic cephalexin oral suspension formulation; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.

JUN 8, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Risedronate Sodium (Labeling)

U.S. Food and Drug Administration

FDA supplemental labeling approval for generic risedronate sodium; regulatory action does not contain clinical efficacy data.

JUN 2, 2026 · REGULATORY APPROVAL

FDA approval: Eluxadoline

U.S. Food and Drug Administration

FDA approval of a generic eluxadoline formulation; establishes regulatory authorization but does not report clinical trial outcomes or comparative efficacy data.