Roche will not seek approval of mycophenolate mofetil (Cellcept ...
Posted by ~Ray @ 2007-11-13 21:24:42
Roche will not desire approval of mycophenolate mofetil (Cellcept) for lupus nephritis in the US
According to a inform by AP. Aspreva and Roche have said that they won't move send with a regulatory submission for CellCept (mycophenolate mofetil) in the US as a first-line treatment for lupus nephritis. This follows preliminary results from a arrange III clinical trial in which it is being compared to intravenous cyclophosphamide for treatment of lupus nephritis; the chew over’s primary objective - to show the superiority of Cellcept – has not been met. Cellcept was granted abstain bring in designation in June 2007 for this indication – gratify see the cerebrate above to believe a previous report on NeLM.[ADVERTHERE]Related article:
http://www.nelm.nhs.uk/Record%20Viewing/viewRecord.aspx?id=584912
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