Fluoxetine · Regulatory label update

FDA supplemental approval: Fluoxetine (Manufacturing (CMC))

U.S. Food and Drug Administration · June 17, 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 application (ANDA 210935) by SciGen Pharms on 17 June 2026 for manufacturing and chemistry changes to generic fluoxetine hydrochloride tablets (10 mg and 20 mg base). This is a regulatory action confirming manufacturing compliance; it does not report clinical trial data, efficacy, or comparative safety.

What was studied

Regulatory label update.

Key findings

Supplemental approval granted for fluoxetine hydrochloride tablet formulations: 10 mg base and 20 mg base oral tablets Approval date: 17 June 2026 Applicant: SciGen Pharms (ANDA 210935)

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes. Applicant: SciGen Pharms (ANDA 210935)

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 an established generic fluoxetine product; does not contain clinical efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval statusApproved

Approval date2026-06-17

Application numberANDA210935

Submission classManufacturing (CMC)

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The approval addresses chemistry, manufacturing, and controls (CMC) only; no comparative bioavailability or clinical evidence is reported.
No information provided on the scope or nature of the specific manufacturing changes approved.

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

This is a regulatory action, not a clinical study.

Directness

insufficient

Record addresses manufacturing compliance, not clinical outcomes.

Consistency

insufficient

No comparative or outcome data reported.

Risk of bias

insufficient

Regulatory approval record; bias assessment not applicable.

Sample adequacy

insufficient

No clinical population or sample described.

Source abstract

Drugs@FDA record for application ANDA210935. This is a regulatory action record, not a clinical study. Brand name: FLUOXETINE. Active ingredient: FLUOXETINE. Sponsor: SCIEGEN PHARMS. Submission type: SUPPL (supplement). Submission class: Manufacturing (CMC). Approval status date: 2026-06-17. Products: FLUOXETINE HYDROCHLORIDE, TABLET, ORAL, FLUOXETINE HYDROCHLORIDE EQ 20MG BASE; FLUOXETINE HYDROCHLORIDE, TABLET, ORAL, FLUOXETINE HYDROCHLORIDE EQ 10MG BASE.

Follow from this

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

Sciegen PharmsFluoxetine