In Brief: Sequus Amphotec
Sequus Amphotec: Liposomal amphotericin B product adds safety data to labeling showing less renal creatinine increase than regular amphotericin B in a study of febrile neutropenic patients. The study's efficacy results were found insufficient to support an indication by an FDA advisory committee ("The Pink Sheet" April 21, T&G-6). Revised labeling notes that "Amphotec is NOT approved for empirical treatment in febrile neutropenic patients." Sequus withdrew the sNDA for the indication in June. Dosing language revised to state "3-4 mg/kg as required"...
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