Strides Pharma Intl

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Acetaminophen AND Codeine Phosphate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for an existing drug-drug combination product with REMS requirements; does not report clinical trial data or comparative efficacy.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Buprenorphine Transdermal System (REMS)

U.S. Food and Drug Administration

FDA supplemental approval for buprenorphine transdermal system REMS; regulatory action without reported clinical trial outcomes.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Hydrocodone Bitartrate AND Acetaminophen (REMS)

U.S. Food and Drug Administration

FDA supplemental approval for a Risk Evaluation and Mitigation Strategy (REMS) governing an existing opioid–acetaminophen combination; documents regulatory action, not clinical evidence of efficacy or safety.

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 hydrocodone bitartrate and acetaminophen combination tablet with REMS requirements; this is a regulatory action, not a clinical trial.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Morphine Sulfate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for morphine sulfate extended-release capsules; this is a regulatory action establishing safety management requirements, not a clinical efficacy study.