Quote:
Originally Posted by Tupelo3
I believe that the US trials are close to completion. The research teams had asked for several extensions. I know for a fact that there have been several issues, such as insertion site infections and tube displacements. I doubt this will ever become a mainstay product. There are other drugs and devices currently being tested that appear to be simpler, safer, and better.
Nevertheless, this is another example of the time delay in the US for getting drugs/products approved. Remember, DatScan received European approval almost 10 years prior to US approval.
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I emailed Abbvie last night and received a phone call from them about an hour ago. That in itself was quite a surprise.
They have submitted a request for review with the FDA and expect to know if it will be approved within the first half of this year!!! Finally! It is now just a matter of months...
I asked about cost and was told that would be determined if/when the FDA approves it. Sorry nothing more specific; regardless, this is really good news.
Laura