Drug or technology
8 developments in the corpus
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JUN 18, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval action for a Risk Evaluation and Mitigation Strategy (REMS) governing an existing hydrocodone–acetaminophen combination product; regulatory actions do not report clinical efficacy or trial outcomes.
JUN 18, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for an existing combination opioid–acetaminophen product; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.
JUN 18, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for hydrocodone bitartrate and acetaminophen tablets across multiple dose strengths.
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; confirms regulatory authorization but does not report clinical trial outcomes.
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 a REMS (Risk Evaluation and Mitigation Strategy) for an existing hydrocodone-acetaminophen combination, affecting distribution and prescribing requirements for opioid-containing pain medication.
JUN 18, 2026 · REGULATORY LABEL UPDATE
U.S. Food and Drug Administration
FDA supplemental REMS approval for hydrocodone bitartrate and acetaminophen combination tablets; regulatory classification only, with no clinical trial data or efficacy comparison.
JUN 18, 2026 · REGULATORY LABEL UPDATE
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.