Guerbet (EPA:GBT), which specializes in medical imaging including contrast agents, has received FDA approval for its Optiray imaging bulk package, which can be used to fill sterile disposable syringes for use with CT imaging.
The imaging bulk package is intended to reduce the number of single-dose vials when used with a power injector and contrast media transfer set. The imaging bulk package does not require a laminar flow hood or pharmacy.
The package will be offered in 500-ml bottles of the Optiray 320 and 350 concentrations of radiopaque contrast agent.
The label for the agents stipulates that they be used within 12 hours once the seal is pierced.
FDA also cleared the Villepinte, France-based company’s LF IBP transfer set.
Like many life sciences companies, Guerbet has seen a drop in core business activity in 2020 as patients in many regions across the world cancel or postpone nonessential radiological examinations and procedures.
The company’s European sales dropped 21.1% in the first six months of the year. Sales were down by a similar amount in the Americas, although business activity increased by about 10% in Asia.