Impax Labs

JUL 22, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling of metformin hydrochloride extended-release tablet; does not report clinical trial data or comparative efficacy.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Oxymorphone Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for a Risk Evaluation and Mitigation Strategy (REMS) programme for oxymorphone hydrochloride extended-release tablets; this is a regulatory decision, not a clinical efficacy or safety study.

APR 21, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Methylphenidate Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling changes for an existing methylphenidate hydrochloride extended-release formulation; does not report clinical trial data.

APR 9, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Doxycycline Hyclate (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling changes to doxycycline hyclate delayed-release tablets; regulatory action without clinical trial data.