Provepharm filed its application with the agency in September 2021, and, with the new approval, its US affiliate will market the product directly in the United States.
The FDA has approved indigotindisulfonate sodium (Bludigo; Provepharm) injection for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults, following gynecological and urological endoscopic, open, or robotic surgical procedures.
Provepharm filed its application with the FDA in September 2021, and, with the new approval, its US affiliate Provepharm Inc will market the product directly in the Unites States.
“Bludigo is the second product to be granted market authorization by the FDA from Provepharm's [research and development] group. This new success validates Provepharm's strategy based on a high level of investment in research and development aimed at improving patients’ lives and health care professionals’ work on a daily basis,” Fredrick Girard, chief medical officer at Provepharm, said in a statement.
It is contraindicated for individuals with known hypersensitivity to indigotindisulfonate or any of its components. The recommended dosage of indigotindisulfonate sodium is 5 mL over the course of 1 minute.
The most common adverse reactions with of indigotindisulfonate sodium in clinical trials were abdominal pain, ALT increase, constipation, dysuria, nausea, pyrexia, and vomiting.
In post-marketing, the adverse reactions for indigotindisulfonate sodium injection products include cardiovascular disorders, such as arrhythmia, asystole, atrioventricular block second degree, bradycardia, cardiac arrest, elevated blood pressure, hypotension, , and tachycardia.
Additionally, investigators noted administration site conditions and general disorders, such as injection site discoloration, as well as immune system disorders, including anaphylactic reactions with hypotension, bronchospasm, dyspnea, erythema, and urticaria.
When using indigotindisulfonate sodium, discard any used portion, do not administer with infusion assemblies used with other diluents or drugs, monitor blood pressure and cardiac rhythm during and following the injection, and use immediately after opening ampoule.
Additionally, withdraw the contents of the ampoule through a 5 micron or smaller filter needle or straw to ensure that the withdrawn solution contains no particulates. The withdrawn solution should be inspected visually for particulate matter and discoloration prior to administration, according to the administration information.
Provepharm announces that it has received FDA approval for Bludigo (indigotindisulfonate sodium, USP) injection. PR Newswire. News release. July 12, 2022. Accessed July 13, 2022. Email.