SUN Pharm Inds

SEP 2, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Oxcarbazepine (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for oxcarbazepine oral suspension labeling; does not report clinical trial outcomes or comparative efficacy data.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Tramadol Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for tramadol hydrochloride REMS; establishes risk mitigation requirements but does not report clinical trial data or efficacy evidence.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Oxycodone AND Acetaminophen (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing oxycodone-acetaminophen combination product; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Meperidine Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval for a Risk Evaluation and Mitigation Strategy (REMS) governing meperidine hydrochloride tablets; this is a regulatory action, not a clinical trial, and does not report efficacy or safety outcomes.