Cephalexin · Regulatory approval

FDA approval: Cephalexin

U.S. Food and Drug Administration · June 9, 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 an original ANDA application for cephalexin oral suspension formulations (250 mg/5 mL and 125 mg/5 mL) from Aurobindo Pharma on 9 June 2026. This is a regulatory action confirming bioequivalence and manufacturing compliance, not a report of clinical trial results or comparative efficacy.

What was studied

Regulatory approval.

Key findings

FDA approval granted for cephalexin oral suspension at two strengths: 250 mg/5 mL and 125 mg/5 mL Application type: ANDA (Abbreviated New Drug Application), indicating generic formulation status Sponsor: Aurobindo Pharma; approval date: 9 June 2026

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes. No dosing recommendations, indications, contraindications, or adverse event profile are provided in this regulatory record.

Who this may help

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

Plain-language summary

FDA approval of a generic cephalexin oral suspension formulation; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-09

Formulation 1 strengthCEPHALEXIN EQ 250MG BASE/5ML

Formulation 2 strengthCEPHALEXIN EQ 125MG BASE/5ML

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
ANDA approval is based on bioequivalence to a reference product; no comparative clinical data are reported here.
No dosing recommendations, indications, contraindications, or adverse event profile are provided in this regulatory record.
No information is given on whether this is a new formulation or a new manufacturer of an existing product.

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 approval record; no clinical study design reported.

Directness

insufficient

Record does not describe clinical outcomes or trial methodology.

Consistency

insufficient

No comparative efficacy or safety data provided in this record.

Risk of bias

insufficient

Record is a regulatory action, not a clinical study with bias assessment.

Sample adequacy

insufficient

No sample size or population data reported in approval record.

Source abstract

Drugs@FDA record for application ANDA213568. This is a regulatory action record, not a clinical study. Brand name: CEPHALEXIN. Active ingredient: CEPHALEXIN. Sponsor: AUROBINDO PHARMA. Submission type: ORIG (original application). Approval status date: 2026-06-09. Products: CEPHALEXIN, FOR SUSPENSION, ORAL, CEPHALEXIN EQ 250MG BASE/5ML; CEPHALEXIN, FOR SUSPENSION, ORAL, CEPHALEXIN EQ 125MG BASE/5ML.

Follow from this

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

CephalexinAurobindo Pharma