FDA approves Bracco's Isovue Readi oral contrast solution
The agency cleared the new formulation under a standard review, with four strengths of iopamidol listed in the application.
The FDA approved Isovue Readi, an oral drug application from sponsor Bracco, on October 9, 2026. The application was filed as NDA220583, a Type 5 submission for a new formulation or new manufacturer, and received a standard review priority.1
The approved product covers four strengths of the active ingredient iopamidol in oral solution form. The listed products include 300mg, 200mg, 370mg, and 250mg strengths, all formulated as oral solutions under the brand name Isovue Readi.1
This marks the original approval (ORIG 1) for the application, with submission number 1 marked as approved (AP) status. The submission status date for the approval is listed as 2026-10-09.1
Supporting documents tied to the approval were dated for release in October 2026. Application documents filed include a product label and an approval letter, both dated 20261013.1
No additional details on indications, dosing regimens, or clinical data supporting the approval were included in the available FDA records for this submission.
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