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