FDA starts safety review of Roche's CellCept and Novartis' Myfortic after cases of PML
The US Food and Drug Administration is investigating two organ transplant rejection drugs to establish whether they increase the risk of a rare but fatal neurological disease. The agency has initiated a safety review of Roche's immunosuppressant CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid), made by fellow Swiss drug major Novartis, after 16 reports of progressive multifocal leukoencephalopathy (PML).
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