The US FDA has posted details, including company and FDA Briefing Materials, for the Wednesday, September 14, 2016 meeting of the Oncologic Drugs Advisory Committee (ODAC), to discuss new drug application (NDA 208714) for apaziquone (also known as Qapzola or EO9) for intravesical instillation, application submitted by Spectrum Pharmaceuticals, Inc. (Spectrum). The proposed indication is for immediate intravesical instillation post-transurethral resection of bladder tumors (TURBT) in patients with non-muscle invasive bladder cancer.
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