Alvogen

AUG 14, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Buprenorphine AND Naloxone Sublingual Film (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a buprenorphine/naloxone sublingual film under REMS; this is a regulatory action, not a clinical evidence report.

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 Risk Evaluation and Mitigation Strategy (REMS) for hydrocodone bitartrate and acetaminophen combination tablets across four dosage strengths.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Hydrocodone Bitartrate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for extended-release hydrocodone bitartrate; this is a regulatory action, not a clinical efficacy study.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (REMS)

U.S. Food and Drug Administration

FDA supplemental REMS approval for hydrocodone bitartrate and acetaminophen fixed-dose combinations; establishes risk mitigation requirements but does not report clinical efficacy or safety trial outcomes.