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Revisions to Mitoxantrone Label Announced
May 25, 2005
May 24, 2005 -- ROCKVILLE, MD -- Serono and FDA notified healthcare professionals of revisions to the BOXED WARNING, WARNINGS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Novantrone [mitoxantrone], indicated for treatment of multiple sclerosis (MS). The Dear Healthcare Professional letter provides additional information concerning the risks of cardiotoxicity associated with Novantrone and also provides supplemental information regarding secondary acute myelogenous leukemia (AML) reported in MS patients treated with Novantrone.
To view the Dear Health Care Professional letter, click here.
Source: The Food and Drug Administration
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