FDA Approves Novel Diagnostic Dye for Endoscopy

The FDA has approved the French company Provepharm’s new drug application for Bludigo (indigotindisulfonate). Bludigo is an indigo carmine injectable, a blue dye that is used as a diagnostic during bladder endoscopy for the assessment of the ureters in adults following surgical procedures.

Damage of the ureters, the ducts carrying urine from kidney to bladder, can occur during urological and gynecological surgery. In fact, 82% of ureter injuries are caused during pelvic surgery and 75% of urinary tract injuries are due to gynecologic surgery, according to one study. If not identified during the surgical procedure, it may lead to severe post-surgical complications, including fistulas and sepsis.

Bludigo was studied in multicenter trial in 118 patients who had an endoscopic urological or gynecological surgical procedure.

Provepharm filed its application for approval with the FDA in September 2021 and with this new approval, its U.S. affiliate, Provepharm Inc., will market the product.

“Bludigo is the second product to be granted market authorization by the FDA from Provepharm’s R&D group,” Frederick Girard, Provepharm’s chief medical officer, said in a press release.