In January 2015 the FDA approved Gadobutrol, known as the brand name Gadavist, as the first magnetic resonance contrast agent for children ages two years and younger. Marketed by Bayer, Gadavist (Gadobutrol) has achieved this unprecedented FDA approval based on comprehensive safety and pharmacokinetic data. Studies of Gadobutrol for pediatric patients ages two and younger involved a standard dose of 0.1 mmol/kg. This dosage proved to be effectual, safe and tolerable for patients, including term neonates. Gadobutrol is known as an efficacious MRI agent for adults and children ages two and older for detecting areas with disrupted blood brain barrier and the abnormal vascularity of the central nervous system in patients.
The study that led to the FDA approval, as aforementioned, involved 47 pediatric patients ranging from ages neonates to 23 months of age. All of the pediatric patients had normal renal function and were from nine centers across the United States, Canada and Europe. Study investigators found that adverse events (AEs) were in line and consistent with results from older patients who were administered Gadobutrol. The most common adverse effects, of a non-serious nature included nasopharyngitis, slight cough, vomiting and nausea. There were no documented serious or fatal AEs reported which related to the use of Gadobutrol. The overall safety profile of Gadobutrol has been documented and studied in over 6,330 patients overall, involved in a plethora of clinical trials.
LGM Pharma can assist clients as a supplier/distributor of the API Gadobutrol, CAS # 138071-82-6 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.
Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.