Specgx

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (REMS)

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

FDA supplemental approval: Acetaminophen AND Codeine Phosphate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval for REMS (Risk Evaluation and Mitigation Strategy) on acetaminophen–codeine phosphate tablets; confirms regulatory compliance but does not report clinical efficacy or comparative benefit data.

JUN 3, 2026 · REGULATORY APPROVAL

FDA approval: Tofacitinib Citrate

U.S. Food and Drug Administration

FDA approval action for a generic tofacitinib citrate formulation; does not report clinical trial outcomes or comparative efficacy data.