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Gabapentin · Regulatory label update
U.S. Food and Drug Administration · April 24, 2026
An action by a regulator. Authoritative on labelling and availability.
This is a U.S. FDA supplemental approval record documenting a labeling change for gabapentin capsules (100 mg, 300 mg, 400 mg formulations) submitted by Ascent Pharms Inc. on 24 April 2026. The record does not contain clinical trial results, efficacy data, or comparative evidence; it is a regulatory action indicating that the agency approved a revision to the product label.
Regulatory label update.
This is a U.S. FDA supplemental approval record documenting a labeling change for gabapentin capsules (100 mg, 300 mg, 400 mg formulations) submitted by Ascent Pharms Inc. on 24 April 2026. The record does not contain clinical trial results, efficacy data, or comparative evidence; it is a regulatory action indicating that the agency approved a revision to the product label.
Record does not contain or reference clinical trial data, efficacy endpoints, or safety outcomes. Record does not indicate the clinical or safety rationale for the labeling change.
This labeling approval does not by itself indicate new efficacy, safety findings, or a change in clinical use. Clinicians should consult the updated label and accompanying prescribing information to identify what text has changed; the regulatory record alone does not specify the nature of the labeling revision.
FDA supplemental approval for labeling changes to gabapentin capsules; a regulatory action that does not report clinical trial outcomes or comparative efficacy data.
Quoted from the source exactly as published.
This labeling approval does not by itself indicate new efficacy, safety findings, or a change in clinical use. Clinicians should consult the updated label and accompanying prescribing information to identify what text has changed; the regulatory record alone does not specify the nature of the labeling revision.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application ANDA214956. This is a regulatory action record, not a clinical study. Brand name: GABAPENTIN. Active ingredient: GABAPENTIN. Sponsor: ASCENT PHARMS INC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-04-24. Products: GABAPENTIN, CAPSULE, ORAL, GABAPENTIN 300MG; GABAPENTIN, CAPSULE, ORAL, GABAPENTIN 400MG; GABAPENTIN, CAPSULE, ORAL, GABAPENTIN 100MG.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.