This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryItraconazole injection and oral solution gains new indication May 9 for empiric therapy in febrile neutropenic patients with suspected fungal infections. FDA issued a public health advisory May 9 advising of hepatotoxicity associated with Sporanox capsules and Novartis' Lamisil (terbinafine) tablets and of "a small but real risk of developing congestive heart failure" with Sporanox. Labeling for both products was revised to strengthen the discussion on hepatotoxicity. A revised boxed warning for Sporanox warns against use of the product in patients with cardiac dysfunction and adds contraindications against administration with dofetilide (Pfizer's antiarrythmic Tikosyn) and pimozide (Gate's antipsychotic Orap)
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