Zyogreen (indocyanine green)

Where it stands

According to the official records, the FDA approved Zyogreen (indocyanine green) on 2026-07-10. The sponsor is Provepharm Sas and the application is NDA218579. The record describes the product as a solution and classifies the approval as a new dosage form.

The records give no therapeutic area and no indication. The labeled use, patient population, route of administration, strength and presentation are therefore not confirmed here. Indocyanine green as an active substance is generally known as a diagnostic dye, but the specific labeled indications for this product should be taken from the approved prescribing information, not from this summary.

The CHMP opinion date is blank. This is expected for a US-only record, since a CHMP opinion belongs to the EU centralised procedure. Nothing in the records indicates EU filing or EU status.

Regulatory pathway and designations

The product was approved under a New Drug Application (NDA218579). The only designation listed is "New dosage form". This is an FDA approval-type classification and generally means the active ingredient is already in an approved product but this application covers a different dosage form. It is not an expedited-program designation.

The records do not list orphan, fast track, breakthrough, priority review or any other expedited designation. They do not state the NDA subtype (for example, whether it relied on published literature or a reference product under 505(b)(2)), the review clock or PDUFA goal date, or any advisory committee activity. Those points cannot be inferred from the data provided.

The only milestone on file is the FDA approval itself, flagged as official. There is no record of earlier submission, acceptance or review events.

Safety and pharmacovigilance

The records contain no safety information. They list no boxed warning, contraindications, warnings and precautions, adverse-reaction data, REMS or postmarketing requirements or commitments.

Readers should consult the approved FDA labeling for Zyogreen for the safety profile. As with any newly approved product, routine pharmacovigilance applies, including adverse event reporting to the sponsor and FDA. Whether any product-specific postmarketing obligations were imposed is not stated in the records.

What to watch

The first step is to retrieve the approval letter and final labeling. They would confirm the indication, dosage form details, any postmarketing requirements and the NDA pathway used.

Other points the records do not cover: US launch timing and availability, any plans for other regions (including an EU submission and CHMP opinion), and any changes to the label after approval. None of these is addressed in the data provided, so no expectations are drawn here.