Pharmobedient

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Acetaminophen, Caffeine AND Dihydrocodeine Bitartrate (REMS)

U.S. Food and Drug Administration

This is an FDA supplemental approval action establishing a Risk Evaluation and Mitigation Strategy (REMS) for a combination opioid-analgesic product; it documents a regulatory decision, not clinical evidence of efficacy or safety.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Oxycodone Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for oxycodone hydrochloride oral solution under REMS requirements; this is a regulatory classification change, not a clinical efficacy finding.

JUN 9, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Azacitidine (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling changes to azacitidine generic product; does not report clinical efficacy or safety data.