Rubicon Research

JUL 10, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Buprenorphine Hydrochloride (Manufacturing (CMC))

U.S. Food and Drug Administration

FDA supplemental approval of a manufacturing/CMC change for an existing buprenorphine hydrochloride product; does not report clinical trial data or comparative efficacy.

JUN 25, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Gabapentin (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval action for gabapentin labeling changes; does not contain clinical trial data or efficacy evidence.

JUN 12, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Clonazepam (Manufacturing (CMC))

U.S. Food and Drug Administration

FDA supplemental approval for manufacturing changes to clonazepam tablets; no clinical efficacy or safety data reported.

MAY 15, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Oxcarbazepine (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for oxcarbazepine labeling update; does not contain clinical trial data or efficacy evidence.

MAY 12, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Lamotrigine (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for lamotrigine tablets; regulatory action without clinical trial data or efficacy claims.