Carfilzomib · Regulatory approval

FDA approval: Carfilzomib

U.S. Food and Drug Administration · July 20, 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 ANDA209526 for generic carfilzomib on July 20, 2026, sponsored by MSN. This approval provides three formulations: 30mg and 60mg injectable preparations, and a 60mg/vial powder for intravenous use.

What was studied

Regulatory approval. Patients requiring carfilzomib treatment as indicated by approved labeling.

Key findings

Approval granted for carfilzomib 30mg injectable injection formulation Approval granted for carfilzomib 60mg injectable injection formulation Approval granted for carfilzomib 60mg/vial powder for intravenous administration

Safety

No efficacy, safety, or comparative bioavailability data reported in this record

Who this may help

This generic ANDA approval may increase access and affordability of carfilzomib. Clinicians should consult prescribing information for indications, dosing, and safety profiles, as this record does not contain clinical efficacy or safety trial data.

Plain-language summary

FDA approval of a generic carfilzomib ANDA expanding access to this proteasome inhibitor formulation.

Study design

As stated by the source record.

PopulationPatients requiring carfilzomib treatment as indicated by approved labeling

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-20

Application numberANDA209526

Submission typeORIG

Clinical bottom line

Caveats

This is a regulatory action record and does not contain clinical trial results
No efficacy, safety, or comparative bioavailability data reported in this record
Specific approved indications not stated in this administrative record
Therapeutic equivalence rating and reference listed drug not specified

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 reported

Directness

insufficient

No efficacy or safety data provided in this record

Consistency

not graded

The material analysed did not support a judgement on this dimension.

Risk of bias

insufficient

Not applicable to regulatory approval records

Sample adequacy

not graded

The material analysed did not support a judgement on this dimension.

Source abstract

Drugs@FDA record for application ANDA209526. This is a regulatory action record, not a clinical study. Brand name: CARFILZOMIB. Active ingredient: CARFILZOMIB. Sponsor: MSN. Submission type: ORIG (original application). Approval status date: 2026-07-20. Products: CARFILZOMIB, INJECTABLE, INJECTION, CARFILZOMIB 30MG; CARFILZOMIB, INJECTABLE, INJECTION, CARFILZOMIB 60MG; CARFILZOMIB, POWDER, INTRAVENOUS, CARFILZOMIB 60MG/VIAL.

Follow from this

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

MSNCarfilzomib