FDA says Alliance Pharma's Imavist "approvable":
This article was originally published in Clinica
Alliance Pharmaceutical's cardiac ultrasound imaging agent Imavist has moved a step closer to US market, after the FDA decided that the agent was "approvable". Final product approval is dependent upon Alliance's submission of additional information related primarily to product labelling. The San Diego, California firm, which is developing the agent jointly with German firm Schering, said it expected to respond to the FDA within the next few weeks. The information that will be supplied to the agency includes patient subgroup analyses, a recently completed pharmacokinetic report and an updated plan for post-approval product release testing.