Fresenius Kabi U

AUG 19, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Colistimethate (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling update to colistimethate sodium injection; this is a regulatory action record without clinical trial data.

JUL 17, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Dexamethasone Sodium Phosphate (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of dexamethasone sodium phosphate labeling; describes regulatory action only, not clinical evidence or efficacy.

JUN 30, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Remifentanil Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for remifentanil hydrochloride; regulatory action does not contain clinical trial data or efficacy evidence.

MAY 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Morphine Sulfate (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of morphine sulfate labeling; regulatory action does not report clinical trial outcomes or efficacy data.

MAY 21, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Tyenne (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling for tocilizumab-aazg (Tyenne); a regulatory action affecting product information but not reporting new clinical trial data.

MAY 20, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Tyenne (Labeling)

U.S. Food and Drug Administration

This is an FDA supplemental approval action for a labeling change to an already-approved drug; it does not report clinical trial results or efficacy data.