Paroxetine · Regulatory label update

FDA supplemental approval: Paroxetine (Manufacturing (CMC))

U.S. Food and Drug Administration · March 26, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

The FDA approved a supplemental ANDA (generic drug application) for manufacturing/chemistry, manufacturing, controls (CMC) changes to paroxetine hydrochloride extended-release tablets at three strength levels (12.5 mg, 25 mg, and 37.5 mg). This is a regulatory action addressing manufacturing specifications and does not include clinical efficacy or safety trial data.

What was studied

Regulatory label update.

Key findings

FDA approval of paroxetine HCl extended-release tablet manufacturing supplement (ANDA217280) on 2026-03-26 Approval covers three tablet strengths: 12.5 mg, 25 mg, and 37.5 mg paroxetine HCl equivalent to base

Safety

This record does not contain clinical trial results, efficacy data, or safety findings.

Who this may help

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

Plain-language summary

FDA supplemental approval of manufacturing changes for paroxetine extended-release tablets; regulatory action with no clinical trial data reported.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-03-26

Product strengths approved12.5 mg, 25 mg, 37.5 mg

Caveats

This record does not contain clinical trial results, efficacy data, or safety findings.
The approval applies only to manufacturing/CMC changes and does not assess comparative bioavailability or clinical outcomes.
No sample size, primary endpoints, or statistical analyses are reported.
The regulatory action does not establish or compare clinical benefit versus other agents.

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 record; no clinical study design present.

Directness

insufficient

Manufacturing CMC approval; no clinical outcomes reported.

Consistency

insufficient

Single regulatory action; no comparative data.

Risk of bias

insufficient

Regulatory submission; clinical trial methodology not applicable.

Sample adequacy

insufficient

No clinical population studied in this submission.

Source abstract

Drugs@FDA record for application ANDA217280. This is a regulatory action record, not a clinical study. Brand name: PAROXETINE. Active ingredient: PAROXETINE. Sponsor: ALEMBIC. Submission type: SUPPL (supplement). Submission class: Manufacturing (CMC). Approval status date: 2026-03-26. Products: PAROXETINE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE; PAROXETINE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, PAROXETINE HYDROCHLORIDE EQ 25MG BASE; PAROXETINE HYDROCHLORIDE, TABLET, EXTENDED RELEASE, ORAL, PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE.

Follow from this

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