ANI Pharms

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Hydrocodone Bitartrate AND Ibuprofen (REMS)

U.S. Food and Drug Administration

FDA supplemental approval for a REMS (Risk Evaluation and Mitigation Strategy) modification to an existing hydrocodone-ibuprofen combination product; this is a regulatory action, not a clinical evidence report.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Oxycodone Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of an opioid formulation under REMS requirements; this is a regulatory action, not a clinical evidence evaluation.