Actavis Labs FL

JUL 1, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Risperidone (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for risperidone orally disintegrating tablet labeling; does not report clinical trial outcomes or comparative efficacy.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for hydrocodone bitartrate and acetaminophen combination tablets; this is a regulatory action establishing safety oversight requirements, not a clinical efficacy or safety trial.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Oxycodone AND Aspirin (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for oxycodone and aspirin combination tablet with REMS requirement; does not report clinical trial outcomes or comparative efficacy.