FDA asks for more Gadolite information:
This article was originally published in Clinica
Executive Summary
The FDA has asked for more information on Gadolite oral suspension, which is currently awaiting approval for use in bowel imaging. The request was made in an approvable letter to manufacturer Pharmacyclics. E-Z-EM recently began selling the agent in the UK, following approval by the Medicines Control Agency (see Clinica No 736/7, p 16). E-Z-EM also has marketing rights for the US, Mexico and Canada.