Hi everyone,
June 22, 2005
Exciting news on the Exjade front please read below. I will be writing a letter regarding this to the FDA and would like to use the list of names collected for the Revlimid letter if that is alright with everyone. I will post the letter when I have completed it, before I send it.
Thanks,
Karen
On June 22, 2005 Novartis announced today that its New Drug Application for Exjade® (deferasirox) has been granted priority review by the U.S. Food and Drug Administration (FDA) as a once-daily oral iron chelator for the treatment of chronic iron overload due to blood transfusions.
A priority review establishes an action date no later than six months after the submission date, which for Exjade was in May 2005. At that time, Novartis also submitted registration applications for Exjade in the European Union, Switzerland and Australia. Exjade, also known as investigational agent ICL670, has also been granted priority review in Australia and fast track status in Switzerland. Further, Exjade has received Orphan Drug status in the U.S., EU and Australia.
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