Lannett CO

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 an existing opioid-acetaminophen combination product; this is a regulatory action, not a clinical trial.

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, representing a regulatory action rather than new clinical evidence of efficacy or safety.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Codeine Sulfate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for codeine sulfate REMS program; describes regulatory classification and product specifications without clinical trial data.

MAR 31, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Valproic Acid (Labeling)

U.S. Food and Drug Administration

This is an FDA supplemental approval action for valproic acid labeling; it documents a regulatory decision, not clinical trial evidence or efficacy data.