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4 developments in the corpus
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JUN 18, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for oxycodone hydrochloride tablets; this is a regulatory action, not a clinical trial, and does not report efficacy or safety trial outcomes.
JUN 18, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval of an oxycodone hydrochloride formulation under REMS; a regulatory action that does not itself report clinical trial outcomes or comparative efficacy.
JUN 18, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing hydrocodone-acetaminophen combination, a regulatory action rather than a clinical evidence assessment.
JUN 18, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval of an oxycodone hydrochloride oral solution formulation under a REMS (Risk Evaluation and Mitigation Strategy) designation; establishes regulatory status but does not report clinical trial outcomes or efficacy data.