Gabapentin · Regulatory label update

FDA supplemental approval: Gabapentin (Manufacturing (CMC))

U.S. Food and Drug Administration · May 14, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This is an FDA supplemental approval for manufacturing and chemistry, manufacturing, and controls (CMC) changes to gabapentin capsules in four dosage strengths (100 mg, 200 mg, 300 mg, 400 mg) submitted by Senores Pharms. The record does not contain clinical trial results, efficacy data, or safety findings, and approval reflects only that manufacturing standards have been met.

What was studied

Regulatory label update.

Key findings

Supplemental ANDA (abbreviated new drug application) approval granted on 14 May 2026 for manufacturing changes to gabapentin capsules

Safety

This is a manufacturing/CMC approval record and contains no clinical trial results, efficacy data, safety data, or comparative effectiveness information.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval for manufacturing changes to gabapentin formulations; does not report clinical efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-05-14

Dosage strengths approved100 mg, 200 mg, 300 mg, 400 mg

Caveats

This is a manufacturing/CMC approval record and contains no clinical trial results, efficacy data, safety data, or comparative effectiveness information.
The record does not specify what manufacturing changes were approved or why the supplement was submitted.
No information on bioavailability, formulation changes, or therapeutic outcomes is provided.

Evidence assessment

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.

Study design

insufficient

Regulatory action record; no clinical study design present.

Directness

insufficient

Manufacturing approval; does not address clinical endpoints or outcomes.

Consistency

insufficient

Single regulatory action; no comparative data reported.

Risk of bias

insufficient

Regulatory submission review; not a clinical efficacy study.

Sample adequacy

insufficient

No human subjects or clinical sample; manufacturing approval only.

Source abstract

Drugs@FDA record for application ANDA219319. This is a regulatory action record, not a clinical study. Brand name: GABAPENTIN. Active ingredient: GABAPENTIN. Sponsor: SENORES PHARMS. Submission type: SUPPL (supplement). Submission class: Manufacturing (CMC). Approval status date: 2026-05-14. Products: GABAPENTIN, CAPSULE, ORAL, GABAPENTIN 200MG; GABAPENTIN, CAPSULE, ORAL, GABAPENTIN 300MG; GABAPENTIN, CAPSULE, ORAL, GABAPENTIN 400MG; GABAPENTIN, CAPSULE, ORAL, GABAPENTIN 100MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

GabapentinSenores Pharms