Epic Pharma

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Methadone Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of methadone hydrochloride REMS establishes risk management requirements; does not report clinical trial efficacy or comparative outcomes.

JUN 8, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Labetalol Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for labetalol hydrochloride tablets; does not contain clinical trial data or efficacy evidence.

JUN 2, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Furosemide (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling changes to furosemide; regulatory action without clinical trial data or efficacy claims.

MAY 5, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Leucovorin Calcium (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling changes to leucovorin calcium tablets; regulatory action confirming revised labeling without new clinical efficacy data.