Tris Pharma

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 hydrocodone bitartrate and acetaminophen oral solution; this is a regulatory action, not a clinical trial, and does not report efficacy or comparative benefit data.