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FDA actions in brief, October 2008 (Cancidas, Aloxi, Vidaza)
Recent FDA approvals and indications (through October 2008) related to Cancidas, Aloxi, and Vidaza.
Caspofungin (Cancidas, Merck) was approved for use in pediatric patients aged 3 months to 17 years as empiric therapy for presumed fungal infections in febrile, neutropenic patients and for the treatment of candidemia and other Candida infections including intra-abdominal abscesses, peritonitis, and pleural space infections, as well as for the treatment of esophageal candidiasis and invasive aspergillosis in patients who are refractory to or intolerant of other therapies. Palonosetron capsules (Aloxi, Eisai/Helsinn Healthcare) were approved for the prevention of chemotherapy-induced nausea and vomiting.
The labeling for azacitidine (Vidaza, Celgene) was expanded to reflect new overall survival data from the AZA-001 survival study in patients with higher-risk myelodysplastic syndromes (MDS). This agent is approved for the treatment of all 5 subtypes of MDS.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
