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Bludigo FDA Approval History

Last updated by Judith Stewart, BPharm on July 19, 2022.

FDA Approved: Yes (First approved July 8, 2022)
Brand name: Bludigo
Generic name: indigotindisulfonate sodium
Dosage form: Injection
Company: Provepharm
Treatment for: Diagnosis and Investigation

Bludigo (indigotindisulfonate sodium) is a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.

  • Damage to the ureters can occur during urological and gynecological surgery and if left unidentified, may lead to severe post-surgical complications. Screening for ureteral damage during the intervention can provide surgeons with an opportunity to repair the damage immediately, and potentially reduce the incidence of post-surgical complications and the need for reintervention.
  • Bludigo is administered intravenously over 1 minute. Blood pressure and heart rhythm should be monitored during and after injection.
  • Warnings and precautions associated with Bludigo include cardiovascular reactions, hypersensitivity reactions, and interference with oximetry measurements.
  • Common adverse reactions include constipation, nausea, vomiting, abdominal pain, pyrexia, ALT increase, and dysuria.

Development timeline for Bludigo

Jul 12, 2022Approval FDA Approves Bludigo (indigotindisulfonate sodium) for Cystoscopic Assessment of the Ureters Following Urological and Gynecological Surgical Procedures

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.