Ascent Pharms

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Oxycodone AND Acetaminophen (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a REMS submission for existing oxycodone/acetaminophen combination tablets; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Methadone Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of methadone hydrochloride under REMS, a regulatory action affecting drug access and safety monitoring requirements, not a clinical efficacy study.

MAY 15, 2026 · REGULATORY APPROVAL

FDA approval: Clomiphene Citrate

U.S. Food and Drug Administration

This is an FDA approval action for a generic clomiphene citrate formulation; it confirms regulatory authorization but does not report clinical trial outcomes or comparative efficacy.

APR 24, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Gabapentin (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling changes to gabapentin capsules; a regulatory action that does not report clinical trial outcomes or comparative efficacy data.