FDA approves Adventapharma's Zueino, an intravenous diclofenac sodium injection

The FDA approved Zueino, a new drug application from Adventapharma DWC LLC, under application number NDA218379. The product is an injectable formulation given intravenously, containing diclofenac sodium at a strength of 37.5MG.¹

The filing was an original submission, numbered ORIG 1. It was classified by the agency as a Type 5 submission, covering a new formulation or new manufacturer, and was reviewed under standard priority rather than an expedited track.¹

The submission's status is listed as "AP," indicating approval. The submission status date tied to this record is September 25, 2026.¹ The FDA's approval letter itself is dated September 29, 2026, and is available as an application document filed with the agency.¹

No further detail is provided in the record regarding the drug's approved indication, dosing regimen, or clinical trial data supporting the application. The record also does not specify whether this approval covers a new chemical entity or references an existing diclofenac sodium product for comparison. Readers seeking indication-specific or efficacy information will need to consult the full approval letter or the product's eventual labeling once posted by the FDA.

As with all newly approved drug applications, additional regulatory documents, including the full prescribing information and any risk management plans, are typically released following final approval and may provide further specifics not captured in this initial database entry.