SUN Pharm Industries

JUL 29, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of metformin hydrochloride labeling; this is a regulatory action, not a clinical trial, and contains no efficacy or safety outcome data.

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 tablets; this is a regulatory action, not a clinical trial, and does not report efficacy or safety trial data.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Methadone Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for methadone hydrochloride REMS; regulatory classification, not efficacy evidence.

MAY 12, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Spironolactone AND Hydrochlorothiazide (Labeling)

U.S. Food and Drug Administration

FDA supplemental labeling approval for a fixed-dose combination antihypertensive; regulatory authorization does not convey clinical efficacy evidence.