Trabectedin · Regulatory approval

FDA approval: Evdi (Type 5 - New Formulation or New Manufacturer)

U.S. Food and Drug Administration · May 1, 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 EVDI (trabectedin solution, 1 mg/20 mL intravenous formulation) on 1 May 2026 under NDA 220837 as a Type 5 submission (new formulation or new manufacturer by Apotex). This approval record contains no clinical efficacy, safety, or comparative trial data and does not establish clinical benefit or superiority.

What was studied

Regulatory approval.

Key findings

Approval date: 1 May 2026 for EVDI intravenous solution formulation (trabectedin 1 mg/20 mL at 0.05 mg/mL concentration)

Safety

This is a regulatory approval record, not a clinical trial; no efficacy, safety, or comparative outcome data are reported. Type 5 submission (new formulation/manufacturer) does not require new clinical trials; approval is based on pharmaceutical equivalence and manufacturing standards.

Who this may help

This regulatory action permits marketing of a new formulation of an existing active pharmaceutical ingredient (trabectedin) by Apotex. Clinicians should refer to the approved labeling and established clinical evidence for trabectedin to inform use; this approval record itself does not provide clinical efficacy or safety data.

Plain-language summary

FDA approval of a new formulation/manufacturer of trabectedin; this is a regulatory action record without clinical trial data or efficacy comparisons.

Reported figures

Quoted from the source exactly as published.

Approved concentration0.05 mg/mL

Approved dose unit1 mg/20 mL

Approval date2026-05-01

Clinical bottom line

Caveats

This is a regulatory approval record, not a clinical trial; no efficacy, safety, or comparative outcome data are reported.
Type 5 submission (new formulation/manufacturer) does not require new clinical trials; approval is based on pharmaceutical equivalence and manufacturing standards.
Clinical evidence for trabectedin's efficacy and safety is not contained in this regulatory record.
No comparative data or comparative clinical benefit vs. other formulations or competitors 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 approval record; no clinical study design present.

Directness

insufficient

Record does not report clinical endpoints or comparative efficacy data.

Consistency

insufficient

Single regulatory action; no comparative or replication data provided.

Risk of bias

insufficient

Regulatory approval record; clinical trial bias assessment not applicable.

Sample adequacy

insufficient

No clinical trial population or sample size reported in this regulatory record.

Source abstract

Drugs@FDA record for application NDA220837. This is a regulatory action record, not a clinical study. Brand name: EVDI. Active ingredient: TRABECTEDIN. Sponsor: APOTEX. Submission type: ORIG (original application). Submission class: Type 5 - New Formulation or New Manufacturer. Approval status date: 2026-05-01. Products: EVDI, SOLUTION, INTRAVENOUS, TRABECTEDIN 1MG/20ML (0.05MG/ML).

Follow from this

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

TrabectedinApotex