Zydus Pharms

JUL 8, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Dexmedetomidine Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of dexmedetomidine hydrochloride labeling; no clinical trial data or efficacy evidence reported in this regulatory action record.

JUN 30, 2026 · REGULATORY APPROVAL

FDA approval: Selenious Acid

U.S. Food and Drug Administration

FDA approval of selenious acid intravenous solution; this is a regulatory action, not a clinical efficacy study, and does not report trial outcomes or comparative benefit.

JUN 2, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Arsenic Trioxide (Labeling)

U.S. Food and Drug Administration

This is an FDA supplemental approval action for labeling of arsenic trioxide; it documents a regulatory decision, not clinical trial evidence or efficacy data.

APR 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Carbamazepine (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for carbamazepine extended-release tablets; does not report clinical trial outcomes or efficacy data.