Somerset Theraps

JUL 6, 2026 · REGULATORY APPROVAL

FDA approval: Varenicline Tartrate

U.S. Food and Drug Administration

FDA approval of a generic varenicline tartrate formulation; regulatory action rather than clinical evidence of efficacy or safety.

MAY 27, 2026 · REGULATORY APPROVAL

FDA approval: Carboprost Tromethamine

U.S. Food and Drug Administration

FDA approval of a generic carboprost tromethamine injectable formulation; represents regulatory authorization but does not report clinical trial data or comparative efficacy.

MAY 6, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Leuprolide Acetate (Labeling)

U.S. Food and Drug Administration

This is an FDA supplemental approval action for labeling changes to leuprolide acetate; it does not report clinical trial outcomes or efficacy data.

APR 1, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Prochlorperazine Edisylate (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling update to prochlorperazine edisylate injectable; this is a regulatory action, not a clinical trial, and does not contain efficacy or safety evidence.